MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION IDRT - TS INTL 1PK 4X10; INTEGRA

Catalog Number 84101

Device Problems Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969); Moisture or Humidity Problem (2986)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported the parcel delivered was okay but inside the parcel the packaging of the device was wet.The customer was concerned of a leakage issue.The issue was discovered at the receipt and delivered for consignment stock.There was no patient impact.

Manufacturer Narrative

Integra has completed their internal investigation on 4may2016.The additional investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: based on the dhr review conducted, there were no abnormalities within the batch record and there is no indication that the production process may have contributed to this complaint.A query of the complaint database for the timeframe of 0mar2015 ¿ 04mar2016 was performed for ce marked wound care products, including idrt-ts, and for lot 105na0336568.There were no additional complaints received for this issue or for the subject lot other than the one described within this report.There were approximately (b)(4) ce marked wound care devices sold in the past 12 months before this complaint.As per the trending query, there has been one (1) complaint identified for leaking or moisture issues.Therefore, the calculated complaint rate is (b)(4).Conclusion - each unit of idrt-ts is sealed in a foil pouch with phosphate buffered saline, then sealed in a tyvek pouch.The filled tyvek pouch is then sent out for sterilization.While the outside of the tyvek pouch is not sterile due to further packaging, the inside of the tyvek pouch remains sterile.The tyvek pouch is then packaged in a trifold box with the ifu and shipped to the distribution center.An uncontrolled environment and changing temperatures during shipping could create condensation within the packaging.Additionally, if the package was exposed to rain then it is possible that the outer boxing dried while the inner packaging remained damp.(b)(4) wiped the trifold box for decontamination purposes; the chemical used during this process seems to have altered the coloring and finish of the box.If there was damage due to water or leaking to the outside of the trifold then any evidence has been compromised with the wipe down.However, there is no indication of moisture or damage to the inside of the trifold.Additionally, as stated in the failure analysis, there is no indication that there is a breach of sterility or that the inner foil pouch or tyvek pouch were subject to a leak.Therefore, at this time the most likely cause of the moisture seen by the customer is due to an uncontrolled environment during shipping.

• Brand Name: IDRT - TS INTL 1PK 4X10
• Type of Device: INTEGRA
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; plainsboro NJ 08536
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5514594
• MDR Text Key: 41183283
• Report Number: 1121308-2016-00006
• Device Sequence Number: 1
• Product Code: MDD
• Combination Product (y/n): N
• PMA/PMN Number: P900033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 84101
• Device Lot Number: 105NA0336568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1