MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN-UNKNOWN PRODUCT ID; PLAINSBORO

Catalog Number XXXDUR

Device Problem Device Expiration Issue (1216)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

It was reported that an expired duragen graft dated (b)(6) 2015 was implanted.There was no patient injury.Additional information has been requested.

Manufacturer Narrative

Integra has completed their internal investigation on 9/24/2015.The investigation included: methods: review of complaints history results: complaint unit was not returned for evaluation since the returned unit was implanted.Neither the packaging of the involved unit was returned for evaluation.Product catalog and lot number was not reported as part of the complaint opening.Since the customer reported that the implanted unit had an expiration date of 07/30/15 it can be inferred that the product information (i.E.Expiration date) was adequately labeled.Every printed label is 100% inspected by quality personnel for correct catalog number, lot number and expiration date.Also as part of the final pack process, the manufacturing personnel verifies the barcode and the piggyback labels for correct catalog number, lot number and expiration date as per procedure ¿duragen labeling and boxing¿.After reviewing the integra lifesciences pr facility complaint system since 2013, only this complaint has been reported regarding to duragen ¿implanted expired duragen graft¿ with a complaint occurrence rate of.(b)(4).Conclusion: the reported condition (implantation of expired duragen graft dated 07/30/15) could not be confirmed as complaint unit was not received for evaluation.Since the finished good lot number was not provided, the device history record (dhr) could not be reviewed and the retain samples could not be evaluated as part of the investigation.The product packaging had several labels which contain the expiration date explicitly.Consequently, this event is considered to be a user error and/or oversight.

• Brand Name: DURAGEN-UNKNOWN PRODUCT ID
• Type of Device: PLAINSBORO
• 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: rowena bunuan ; 311 enterprise drive; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5077141
• MDR Text Key: 25776635
• Report Number: 1121308-2015-00020
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K982180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXXDUR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other