MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR BIOPATCH 4152

Catalog Number 4152

Device Problems Sticking (1597); Delamination (2904)

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

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident is not expected to be received for evaluation.An investigation has been initiated based upon the reported information.

Event Description

Total of 3 complaints opened for this event to capture the issue/lot numbers.This is report 1 of 3.It was reported by the sales rep.That during dressing changes, the blue top is delaminating from the foam and wrapping around the catheter.This is reported to be happening "every time", but no specific number of occurrences has been recorded.He also states there is a difference in the feeling of the device.No patient consequences were reported.No product has been saved.

Manufacturer Narrative

This is the 1st of 3 reports from the same customer, same product problem, different product id/lot numbers: 2648988-2015-00058; 2648988-2015-00059; 2648988-2015-00060.Additional information received (b)(6) 2015: catheter dislodgement is a concern.When the product delaminates, the blue scrim is wrapping around the catheter, which may lead to a potential dislodgement.Also, the customer normally experiences delamination when the product is saturated; however, they now experience delamination even when the product is dry.Dressing change protocol is for 7 day dressing change, but dressings are changed prn if needed.The skin prep is allowed to dry prior to the product application, per protocol.Three m transparent film dressing is the cover dressing used over the product.Integra has completed their internal investigation on (b)(6) 2015.The additional investigation activities included: methods: review of device history records.Review of complaint history.Results: device history record (dhr) of the finish good (fg) lot # 1151042 was reviewed in order to detect any anomalies that could have occurred during the manufacturing process of the product which could have contributed and/or be related with the reported condition being investigated (blue top delamination).The manufacturing date is 03-2015 and the expiration date is 03-2017.As part of the manufacturing process, controls are in place to detect delamination of the scrim from the foam.A 100% visual inspection for proper adhesion between the scrim and foam is performed by manufacturing personnel as per applicable procedure and by quality control.Scar records initiated from 2013 were reviewed for any supplier nonconformance regarding the blue film material.No scars have been issued during this period that could be related to the reported condition (blue top delamination).No ncrs have been issued that could be related to the reported condition (blue top delamination).Capa (b)(4) was issued on (b)(6) 2013 to re-evaluate the biopatch manufacturing process and raw materials in order to look for potential causes that could contribute to the adhesion condition on dry chg drug loaded polyurethane foam.Although a root cause could not be determined given that the adhesion condition was not confirmed and no changes have been made to the foam, raw materials or to the biopatch manufacturing process, it was found that a specification for the scrim peel adhesion (test performed by the supplier) was not included as part of the certificate of compliance of the material.Capa was closed on (b)(6) 2014.As a corrective action, spec (b)(4) was revised to include the recommended specification for peel adhesion.(b)(4) retain samples from fg lot # 1151042 were evaluated as part of this investigation.All units were visually and physical tested for foam/scrim adhesion.Attempts were made to remove the scrim from the dry foam.Removal was not possible given that good adhesion was observed between the two materials for all units evaluated.Upon review of integra's complaint system since 2013, a total of (b)(4) complaints (including this one) related to delamination for biopatch product family have been reported.Approximately (b)(4) units have been released for distribution since (b)(4) 2013 - (b)(6) 2015, resulting in a complaint occurrence rate of approximately (b)(4)%.Conclusion: based on information provided in complaint record and failure analysis of unit received for evaluation, the reported incident (blue top delamination) could not be confirmed.No assignable causes that could be associated to the manufacturing process of biopatch were determined based on the review of dhr, ncr's, scar's and retain samples evaluation.Therefore, a potential root cause for blue film delamination may be due to an oversaturated dressing since the adhesive used on the film (pn: (b)(4)) material ((b)(4)) is dispersible in water.Consequently, an oversaturated dressing has the potential to cause detachment of the scrim material from the chg drug loaded polyurethane foam.This oversaturation condition is not related to a malfunction of the biopatch disk and does not affect the drug release effect of the product.

Manufacturer Narrative

Two (2) unused representative samples from catalog 4152, ¿biopatch® protective disc with chg¿ corresponding to fg lot # 1151042 and 1150571 were received for evaluation in its original packaging on (b)(6) 2015.The unit from fg lot # 1151042 was compared with unit from fg lot # 1150571 (labeled as good product for comparison only).No differences were noticed between the units in terms of foam/scrim texture and adhesion.Unit from fg lot # 1151042 was visually and physically evaluated for foam/scrim adhesion.Several attempts were made to remove the scrim from the dry foam.Removal was not possible given that good adhesion was observed between the two materials.The investigation performed was for fg lot # 1151042.Therefore, root cause analysis is being updated to correct typo error in fg lot #.Based on information provided in complaint record and failure analysis of unit received for evaluation, the reported incident (blue top delamination) could not be confirmed.No assignable causes that could be associated to the manufacturing process of biopatch were determined based on the review of dhr, ncr's, scar's and retain samples evaluation.As part of capa , corrective actions were implemented on november 26, 2014.Although fg lot # 1151042 was manufactured after capa implementation, the blue nylon film material used for the manufacture of fg lot # 1151042 was manufactured prior to corrective action implementation.However, no issues indicating poor adhesion between scrim and foam were noticed based on failure analysis of returned unit and retain samples evaluation.

• Brand Name: BIOPATCH 4152
• Type of Device: BIOPATCH
• Manufacturer (Section D): INTEGRA NEUROSCIENCES PR; anasco PR 00610
• Manufacturer (Section G): INTEGRA NEUROSCIENCES PR; road 402 north, km 1.2; anasco PR 00610
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 8006542873
• MDR Report Key: 4938360
• MDR Text Key: 22723454
• Report Number: 2648988-2015-00058
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003229
• 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
• Report Date: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4152
• Device Lot Number: 1151042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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