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

Catalog Number XXX-BIOPATCH

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Bacterial Infection (1735); Death (1802); Endocarditis (1834); Unspecified Infection (1930); Thrombus (2101)

Event Type  Injury  

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

Pediatr nephrol (2006) published "predictors and outcome of catheter-related bacteremia in children on chronic hemodialysis" retrospective chart review was performed in 70 children who were chronically dialyzed in the pediatric hemodialysis unit from january 1999 to december 2003.Hemodialysis catheters were handled only during dialysis sessions with no intervention between treatments.Since the year 2001, the protocol for exit site care was to clean with betadine solution, apply a biopatch®(chlorhexidineimpregnated dressing), and cover with a transparent dressing (tegaderm).This process was repeated once a week.The mean age (±sd) of the patients was 13.9±4.6 years.Of the 70 children, 14 (20%) had av fistulas or grafts at initiation or during the course of the study; 59 (84%) had chronic hemodialysis catheters (including 4 who later had fistulas or grafts).Results: gram-positive bacteremia was significantly more prevalent than gramnegative bacteremia, with an average occurrence of 67% over the 5 years.Gram-positive isolates were resistant to oxacillin in 76.4 and sensitive to vancomycin in 99.3% of cases.Tobramycin resistance was demonstrated in 22% of gram-negative crb.This resistance increased to 72% in polymicrobial infections.Of all gram-negative isolates, 100% were sensitive to levofloxacin.No polymicrobial infections were encountered with first catheter infections where gram-negative organisms constituted 17%.Infection with pseudomonas occurred in four blood cultures.Infection cleared with systemic antibiotic therapy and antibiotic- heparin lock in two children; catheter exchange was required in two.The patient¿s treatment modality depended on their initial response to systemic antibiotics.Systemic antibiotic therapy cleared the crb in 64 of 188 (34%) cases; the addition of antibiotic-heparin locks cleared the initial bacteremia in an additional 23%; 81 of 188 (43%) crb required early catheter exchange (in 2-7 days) in addition to systemic antibiotics.Three patients failed their initial treatment regimen (short-term outcome endpoint).Two of the three died despite removal of the infected catheter.Their cause of death was multifactorial and related to complications from hiv infection.Crb recurred in 55 of 188 (29%) after 6 weeks of initial therapy.A total of 275 cardiac echocardiograms were performed on the 60 patients.Six patients were diagnosed with a thrombus at the catheter tip extending into the right atrium.Five of these had recurrent crb and four patients had bacterial endocarditis including two with a thrombus.".

Manufacturer Narrative

Integra has completed their internal investigation on january 17, 2018 results: a failure analysis from the reported event is not possible.No catalog and/or lot number was provided for evaluation and no biopatch unit was returned since this is from published report from 2006.Dhr review; no device history record was possible since no lot number was identified by the customer.Complaints history; after reviewing the integra lifesciences complaint system since december 2015 to december 2017, eight (8) complaints (including the one being investigated) related to the condition ¿infection¿ have been reported on biopatch family.(b)(4).Conclusion: no assignable causes that could be associated to the reported condition were found in the biopatch manufacturing or packaging process based on the review of current practices, scars, capas, and ncrs history.The reported condition could not be confirmed.The customer did not provide information about the catalog and lot number and if the product is directly related to this event.Also, in the product ifu state that ¿the safety and effectiveness of biopatch has not been established in children under 16 years of age¿.There are controls in place during the process such as gowning, controlled areas, area and product monitoring, and validated sterilization cycles to prevent this type of events, therefore, it is not possible to determine a root cause for the reported condition.A possible root cause for the reported condition ¿infection¿ may be related to the patients multifactorial and complications as was described in the publication.

• 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: 7140682
• MDR Text Key: 95655799
• Report Number: 2648988-2017-00071
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-BIOPATCH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2018
• 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