MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH, UNKNOWN SIZE/PRODUCT ID; ANTIMICROBIAL PRODUCTS

Catalog Number XXX-BIOPATCH

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

It was reported by the customer that they have experienced an occurrence of biopatch adhering to a picc.The blue part stuck to the dressing, it surrounded and stuck to the picc line also.The dressings are changed every 7 days.Scissors were used to cut through the transparent dressing and the biopatch to remove the biopatch.There was no draining from the picc line.Exudate was not dried solid at the time of biopatch removal.The customer is unable to verify if the skin prep was allowed to dry prior to the biopatch application.Vygon (b)(4) cover dressing was being used over the biopatch.There have been no patient consequences.

Manufacturer Narrative

Integra has completed their internal investigation on april 27, 2016.The investigation included: methods: review of device history records.Review of complaints history.Results: evaluation of returned device; no samples have been received at the time of this evaluation.The reported condition cannot be confirmed.Dhr review; the finished good (fg) lot # 1153168 was released for distribution on august 31, 2015 in compliance with the product specifications and integra requirements.No anomaly or discrepancies were reported during the manufacture of the fg lot that could be related to the reported condition (blue top delamination).Complaints history; there is no other complaint generated to lot 1153168.Upon review of integra's complaint system from (b)(6) 2014- (b)(6) 2016, a total of (b)(4) complaints (including this one) related to delamination / adhering to picc for biopatch product family.(b)(4).Conclusion: no product malfunction or any defect that could be associated to lot 1153168 manufacturing process was identified.The polyurethane disk contacting the wound acts like a sponge that absorbs exudate/moisture from the wound.With highly exudative wounds, the moisture from the exudate could soften the medical grade acrylic adhesive and make the blue nylon reinforced film (scrim) more easily to peel.In this case, detachment of the blue nylon reinforced film from the biopatch disk is possible due to the pulling force exerted during the removal of the transparent film dressing that secures the device and biopatch disk to the skin.Since detachment of the blue nylon reinforced film (scrim) is most likely to occur during removal of the biopatch disk, which is then discarded, it has no impact on patient care.As per application process, biopatch is used in conjunction with other products (e.G.Skin prep, transparent film dressing) which when combined may contribute to blue film catheter adherence issues.Regarding the scrim ¿surrounding¿ the picc line it is most probable related to product handling when removing the dressing.Since the scrim is attached to the transparent film, it cannot wrap the picc line on its own and thus it is most likely to be wrapped around the picc line when handling during transparent film/device removal.When slit of device is aligned correctly with catheter, biopatch will remain attached to the transparent film dressing and removal will be simultaneous.

• Brand Name: BIOPATCH, UNKNOWN SIZE/PRODUCT ID
• Type of Device: ANTIMICROBIAL PRODUCTS
• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5545551
• MDR Text Key: 42493631
• Report Number: 2648988-2016-00014
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BIOPATCH
• Device Lot Number: 1153168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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