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

Catalog Number XXX-BIOPATCH

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

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

World neurosurgery (2017) published "a simple infection control protocol durably reduces external ventricular drain infections to near-zero levels" this report is a retrospective analysis of evds placed in the intensive care unit of a tertiary neurosurgical center over an additional 4 year follow-up period.Evd dressing in the protocol involves tunneling by 3e5 cm, a question-mark array of surgical staples to secure the catheter, tincture of benzoin, a chlorhexidine-eluting patch (biopatch), a large transparent dressing (tegaderm; 3m medical,), and adhesive strips (steristrips; 3m medical).Results: in the 4-year follow-up period, 189 evds were placed in 173 patients.The previously observed decrease in cerebrospinal fluid culture positivity from 9.8% in the baseline period to 0.8% in the first 3 years of the protocol period continued in the 4-year follow-up period (0%, 0 of 189 evd placements, 0 per 1000 catheter-days; p < 0.001 compared with baseline).The previously observed decrease in the rate of ventriculitis from 6.3% to 0.8% also continued in the follow-up period (0%, 0 of 189 evd placements, 0 per 1000 catheter-days).Over the total 7 years of protocol use, the rate of culture positivity was 0.3% (1 of 308 evd placements, 0.29 per 1000 catheter-days) and the rate of ventriculitis was 0.3% (1 of 308 evd placements, 0.29 per 1000 catheter-days).The only observed infection over 7 years occurred in a patient who removed their own evd.

Manufacturer Narrative

Integra has completed their internal investigation on january 17, 2018.Results: evaluation of returned device; a failure analysis from the reported event is not possible.No catalog and lot number was provided for evaluation and no biopatch unit was reported to be returned.Dhr review; no device history record (dhr) was possible since no lot number was identified by the customer.Complaints history; after reviewing the integra complaint system since december 2015 to december 2017, eight (8) complaints (including the one being investigated) related to the condition ¿observed infection¿ have been reported on biopatch family.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.

• 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: 7143150
• MDR Text Key: 95727541
• Report Number: 2648988-2017-00067
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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