MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET; N/A

Catalog Number PAC1

Device Problems Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311); Material Deformation (2976); Material Integrity Problem (2978); Scratched Material (3020)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Scratches and dents was reported on the device when received by the distributor for customer delivery.No patient involvement.

Manufacturer Narrative

Integra completed its internal investigation (b)(6) 2016.Device history record reviewed for serial number (b)(4).No non-conformance reports were raised during the manufacturing process for this cable.A minimum of 12-month review of pac-1 customer complaints was completed using the following key words ¿cosmetic issue¿ and ¿root cause not determined¿ in search criteria.The key word search review of the complaints contained all and/or part of the key words to complete a comprehensive trend review from (b)(6) 2015 to (b)(6) 2016.One complaint was identified that contained the search criteria.The complaint rate for reported failure is 0.003%.Reported failure was confirmed; although during investigation the pac-1 cable tested within specifications, scratches were found on the cable housing during visual inspection.Customer complaint was confirmed, however, root cause not determined.No corrective/preventative action is deemed necessary as no trend has been identified.

• Brand Name: PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5822422
• MDR Text Key: 51239094
• Report Number: 3006697299-2016-00161
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• 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: 07/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: PAC1
• Device Lot Number: 542135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1