MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. EVA TDC VITRECTOMY PACK VGPC INPUT 25G; SURGICAL PACKS AND KITS

Catalog Number 8310.25G12

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/03/2023

Event Type  malfunction  

Event Description

We have been informed that the packaging is not properly sealed.The product has not been used.No patient harm occurred.

Manufacturer Narrative

The complaint is under investigation.No corrective or preventive actions can be implemented until the investigation has been completed.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Manufacturer Narrative

The involved product was received at dorc on march 23, 2023.Visual examination confirmed the compromised seal.Further investigation as to the cause of the compromised seal is currently ongoing.

Event Description

We have been informed that the packaging is not properly sealed.The product has not been used.No patient harm occurred.

Manufacturer Narrative

Investigation confirmed the compromised seal.Device history record review revealed no deviations.Based on outcome of the upcoming multi-disciplinary investigation, possible corrective an/sor preventive actions will be taken.

Event Description

We have been informed that the packaging is not properly sealed.The product has not been used.No patient harm occurred.

Manufacturer Narrative

In regard to this complaint, six eva tdc vitrectomy pack vgpc input 25g packs were received for investigation.Visual inspection of the returned product confirmed that the tyvek lids were no longer properly sealed.Device history record review revealed no anomalies.A systematic investigation of the identified potential contributors or causes concluded that the most probable cause of the seal failure 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 5degrees celsius 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 compromised seals in this case most likely occurred from a double fault scenario where the products were not [?]handled with care' (i.E.Consistent with normal transport conditions) and shipped under temperature conditions on-route around or even below freezing point via specific shipping lines.To avoid the potential of compromised seals due to the double fault scenario identified, a box-in-box principle was implemented during the "cold season" for cartons that are shipped individually via the specific shipping lines.The box-in-box principle has proven to reduce the impact of rough handling significantly; however, it did not eliminate the issue completely.An investigation on how to improve the seals itself is currently ongoing.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 was implemented during the "cold season" for cartons that are shipped individually via the specific shipping lines.The box-in-box principle has proven to reduce the impact of rough handling significantly; however, it did not eliminate the issue completely.An investigation on how to improve the seals itself is currently ongoing ((b)(4) ).The analysis includes all similar complaints (failure mode as evaluated pack-packaging-seal-cold shock).The incident numbers are all up to date; however, due to a data management changes, the distribution numbers of 2023 are only partial.As the actual distribution numbers are considerately higher, the table provides a worst case scenario on the failure rates.

Event Description

We have been informed that the packaging is not properly sealed.The product has not been used.No patient harm occurred.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 25G
• Type of Device: SURGICAL PACKS AND KITS
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16751144
• MDR Text Key: 313431086
• Report Number: 1222074-2023-00024
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 2000440853
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/10/2023; 06/27/2023; 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1