MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH 4150

Catalog Number 4150

Device Problems Migration or Expulsion of Device (1395); Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  malfunction  

Event Description

It was reported by the customer that while changing the dressing on a picc ine where biopatch was used, the top, blue part of the biopatch sticks too much to the dressing and starts to pull out the picc line.The picc line did not come fully out and there was no consequence to the patient.The customer had to use two nurses to change the dressing.No product will be returned.

Manufacturer Narrative

Integra has completed their internal investigation on december 18, 2017.Results: dhr review; no lot number was provided, thus no dhr review was possible.Complaints history; from november 2015 to november 2017, a total of six (6) complaints related to interaction with the picc line for biopatch product family.(b)(4).Conclusion: given that no return samples will be received and no photos were sent as part of the complaint information, the reported incident could not be confirmed.

• Brand Name: BIOPATCH 4150
• Type of Device: BIOPATCH
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; road 402 north, km 1.2; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7079168
• MDR Text Key: 94978447
• Report Number: 2648988-2017-00055
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• PMA/PMN Number: K003229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• 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