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 Unspecified Infection (1930); Skin Inflammation (2443)

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

Pediatrics (2001) published "a randomized trial comparing povidone-iodine to a chlorhexidine gluconate-impregnated dressing for prevention of central venous catheter infections in neonates".The authors report the results of a multicenter prospective, randomized trial undertaken to ascertain the efficacy of a novel chlorhexidine-impregnated dressing for the prevention of catheter colonization and catheter-related blood stream infection (crbsi) in critically ill neonates.This study was conducted in 6 level iii neonatal intensive care units from june 1994 to august 1997.Neonates admitted to units who would likely require a central venous catheter (cvc) for at least 48 hours were eligible for the study.After obtaining parental consent, 705 neonates were block randomized to 1 of 2 treatment groups: chlorhexidine dressing: n=335 (59% male; mean birth weight 1640+/-50g), and povidone iodine: n=370.Neonates randomized to the control skin care regimen had the catheter insertion site cleansed for at least 30 seconds with povidone iodine (pi); after the pi was allowed to dry, the cvc was inserted and then dressed with a polyurethane dressing (bioclusive transparent dressing, johnson and johnson medical).Neonates randomized to the novel chlorhexidine dressing (biopatch antimicrobial dressing, johnson and johnson medical) had the insertion site cleansed for at least 30 seconds with 70% isopropyl alcohol; after the alcohol dried, the catheter was inserted, and the insertion site was covered with the chlorhexidine dressing.The site was then dressed with the same type of polyurethane dressing used in the control group.During the entire study period, 15 of 98 neonates <1000g and 4 of 237 neonates >/=1000g randomized to the antiseptic dressing group developed a contact dermatitis under the dressing.A substantial risk of contact dermatitis at the dressing site may limit the use of biopatch in low birth weight infants in the first 2 weeks of life.".

Manufacturer Narrative

Integra has completed their internal investigation on january 19, 2018.Results: the units involved in the reported incident were used during the medical study performed between june 1994 to august 1997 and are not available to perform a failure analysis.Thus, the reported condition of ¿dermatitis¿ is unconfirmed.Dhr review; could not be performed since no catalog /lot number was reported.Complaints history; upon review of integra's complaint system from december 2015 ¿ january 15, 2018, a total of 43 complaints (including the one under evaluation) related to ¿contact dermatitis and/ or adverse reaction¿ for biopatch product family.Eighteen of these 43 complaints are related to children or babies, for which safety and effectiveness of the device has not been established as indicated in the ifu.(b)(4).Conclusion: the ifu warns: ¿do not use biopatch on premature infants.Use of this product on premature infants has resulted in hypersensitivity reactions and necrosis of the skin.¿the safety and effectiveness of biopatch® has not been established in children under 16 years of age.Biopatch¿s ifu literature recognizes the possibility of an adverse reaction: ¿adverse reactions to chlorhexidine gluconate such as dermatitis, hypersensitivity, and generalized allergic reactions are very rare, but if any such reactions occur, discontinue use of the dressing immediately.¿.

• 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: 7142508
• MDR Text Key: 95735370
• Report Number: 2648988-2017-00061
• 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: 01/19/2018
• 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