MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA TDC VITRECTOMY PACK VGPC INPUT 27G; SURGICAL PACK AND KITS

Catalog Number 8310.25G12

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Manufacturer Narrative

The product has been returned for investigation.Investigation of the product confirmed that the tyvek lid on the blister was no longer properly sealed.Dhr review did not reveal any anomalies.Through systematic investigation of the identified potential contributors or causes , all but two factors were excluded as potential contributors to the root cause of the reported event.The remaining potential factors to cause the reported complaint are handling and temperature during distribution.Based on the outcome of the investigation performed we are confident that when products are [?]handled with care' (i.E.Consistent with normal transport conditions) during transport the seal integrity will not be compromised to a degree that products will not meet specification.However, the product subject to the reported event was shipped under conditions while outside temperature conditions on-route during the actual transport to those end customers have likely been around or in most cases even below freezing point.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.No corrective or preventive actions can be implemented until the investigation has been completed.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.Specifically mobile monitoring equipment has been received.Collection of data on temperature and potentially unintended high handling forces during transport to the related customer will be initiated.Results will be included in the final report.

Manufacturer Narrative

The product has been returned for investigation.Investigation of the product confirmed that the tyvek lid on the blister was no longer properly sealed.Dhr review did not reveal any anomalies.Through systematic investigation of the identified potential contributors or causes, all but two factors were excluded as potential contributors to the root cause of the reported event.The remaining potential factors to cause the reported complaint are handling and temperature during distribution.Based on the outcome of the investigation performed we are confident that when products are [?]handled with care' (i.E.Consistent with normal transport conditions) during transport the seal integrity will not be compromised to a degree that products will not meet specification.However, the product subject to the reported event was shipped under conditions while outside temperature conditions on-route during the actual transport to those end customers have likely been around or in most cases even below freezing point.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.No corrective or preventive actions can be implemented until the investigation has been completed.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.Specifically mobile monitoring equipment has been received.Collection of data on temperature and potentially unintended high handling forces during transport to the related customer has been initiated.Unfortunately the data loggers have not yet all been received back for analysis.Results will be included in the final report.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Manufacturer Narrative

The product has been returned for investigation.Investigation of the product confirmed that the tyvek lid on the blister was no longer properly sealed.Dhr review did not reveal any anomalies.Through systematic investigation of the identified potential contributors or causes , all but two factors were excluded as potential contributors to the root cause of the reported event.The remaining potential factors to cause the reported complaint are handling and temperature during distribution.Based on the outcome of the investigation performed we are confident that when products are 'handled with care' (i.E.Consistent with normal transport conditions) during transport the seal integrity will not be compromised to a degree that products will not meet specification.However, the product subject to the reported event was shipped under conditions while outside temperature conditions on-route during the actual transport to those end customers have likely been around or in most cases even below freezing point.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.No corrective or preventive actions can be implemented until the investigation has been completed.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.Specifically mobile monitoring equipment has been received.Collection of data on temperature and potentially unintended high handling forces during transport to the related customer has been initiated.Unfortunately the result of the data loggers were not consistent.Further investigation is ongoing.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Manufacturer Narrative

The product has been returned for investigation.Investigation of the product confirmed that the tyvek lid on the blister was no longer properly sealed.Dhr review did not reveal any anomalies.Through systematic investigation of the identified potential contributors or causes , all but two factors were excluded as potential contributors to the root cause of the reported event.The remaining potential factors to cause the reported complaint are handling and temperature during distribution.Based on the outcome of the investigation performed we are confident that when products are (handled with care' (i.E.Consistent with normal transport conditions) during transport the seal integrity will not be compromised to a degree that products will not meet specification.However, the product subject to the reported event was shipped under conditions while outside temperature conditions on-route during the actual transport to those end customers have likely been around or in most cases even below freezing point.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.No corrective or preventive actions can be implemented until the investigation has been completed.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.Specifically mobile monitoring equipment has been received.Collection of data on temperature and potentially unintended high handling forces during transport to the related customer has been initiated.Unfortunately the result of the data loggers were not consistent.Results of additional tests are pending a final conclusion to be reported in the final report.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Manufacturer Narrative

The product has been returned for investigation.Investigation of the product confirmed that the tyvek lid on the blister was no longer properly sealed.Dhr review did not reveal any anomalies.Through systematic investigation of the identified potential contributors or causes , all but two factors were excluded as potential contributors to the root cause of the reported event.The remaining potential factors to cause the reported complaint are handling and temperature during distribution.Based on the outcome of the investigation performed we are confident that when products are (handled with care' (i.E.Consistent with normal transport conditions) during transport the seal integrity will not be compromised to a degree that products will not meet specification.However, the product subject to the reported event was shipped under conditions while outside temperature conditions on-route during the actual transport to those end customers have likely been around or in most cases even below freezing point.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.No corrective or preventive actions can be implemented until the investigation has been completed.Further investigation into the effect of handling in combination with low temperatures on the seal quality is ongoing.Specifically mobile monitoring equipment has been received.Collection of data on temperature and potentially unintended high handling forces during transport to the related customer has been initiated.Unfortunately the data loggers have not yet all been received back for analysis.Results will be included in the final report.The product has been returned for investigation.Investigation of the product confirmed that the tyvek lid on the blister was no longer properly sealed.Dhr review did not reveal any anomalies.A systematic investigation of the identified potential contributors or causes concluded that the most probable cause of the observed complaint is neglecting the shipping carton labeling of 'handle with care' of individual cartons at low temperatures during transport.This conclusion was reached through extensive testing.It was confirmed that seal integrity can become affected by rough handling (e.G.Dropping cartons on the edges) from temperatures below 5°c and that this effect increases with decreasing temperature.It was also confirmed that when cartons are handled with care as indicated on the carton labeling, or are transported on pallets, the seal integrity is not affected at lower transport temperatures.The product subject to the reported event was shipped via transfer hubs of carriers to the end customer under outside temperature conditions that have likely been around or in most of the time even below freezing point.This knowledge on the transport conditions in combination with the result of the internal testing supports the most likely cause of the reported event as a double fault scenario where the products involved were not 'handled with care' as indicated on the product labeling (i.E.Consistent with normal transport conditions) and shipped under temperature conditions on-route around or in most cases even below freezing point via specific shipping lines.Hence, based on the outcome of the investigation performed we are confident that when products are 'handled with care' (i.E.Consistent with normal transport conditions) during transport, the seal integrity will not be compromised to a degree that products will not meet specification.To avoid the potential of compromised seals due to the double fault scenario identified, a box-in-box principle will be implemented during the "cold season" for cartons that are shipped individually via the specific shipping lines identified.The box-in-box principle has proven to reduce the impact of rough handling significantly.The risk identified is included in the risk management documentation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.To avoid the potential of compromised seals due to the double fault scenario identified, a box-in box principle will be implemented during the "cold season" for procedure packs packaged individually with transport dependent on the specific shipment lines identified.The box-in-box principle will be implemented in (b)(6) 2021.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 27G
• Type of Device: SURGICAL PACK AND KITS
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 11855640
• MDR Text Key: 251703724
• Report Number: 1222074-2021-00038
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8310.25G12
• Device Lot Number: 2000418959
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1