MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA NEXUS¿ CARTRIDGE WITH 0,5 L COLLECTION BAG; SURGICAL PACKS AND KITS

Catalog Number 9100.CAR01

Device Problem Unsealed Device Packaging (1444)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

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

In regard to this complaint, three eva cartridge packs were received for investigation, one opened and two unopened.Visual inspection of the returned products confirmed that the tyvek lid was 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 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 being subjected to outside temperature conditions that have likely been around or, in most cases, 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 project is currently ongoing to improve the seal strength.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 (dtp 2021-035).Number of similar events was determined as events with failure mode as evaluated pack-packaging-seal-coldshock and numbers for 2024 include this case.Number of devices sold are products in the same product group (9100.Car01, 9100.Car02, and 9100.Car03).

Event Description

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

• Brand Name: EVA NEXUS¿ CARTRIDGE WITH 0,5 L COLLECTION BAG
• Type of Device: SURGICAL PACKS 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: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 18796042
• MDR Text Key: 336400612
• Report Number: 1222074-2024-00007
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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: 9100.CAR01
• Device Lot Number: 20306.*.*.1
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1