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

Catalog Number XXX-BIOPATCH

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Irritation (1941); Skin Irritation (2076)

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

American journal of infection control (2007) published "the use of 2% chlorhexidine (chg) skin antisepsis for the prevention of infection with central venous catheters (cvc) in a neonatal intensive care unit (nicu)".The objective of this project was to implement measures during insertion and maintenance of central venous catheters (cvcs) as a means to decrease catheter-associated bloodstream infection (bsi) in the neonatal population.Beginning in march 2006, the use of chlorhexidine (chg) for skin antisepsis was implemented.The targeted population was neonates admitted to the nicu who require the placement of percutaneously inserted central catheters (picc) or broviac catheters for fluid/medication administration.These were limited to use in infants greater than 2 weeks of age or weighing more than 2 kilograms due to lack of data regarding the use of chg in neonates.At the same time, the use of a chg impregnated patch (biopatch) was implemented for those neonates with broviac catheters.There were 2 patients out of 56 that developed minor skin irritation with the use of the chg patch.".

Manufacturer Narrative

Integra has completed their internal investigation on january 17, 2018.Results: the units involved in the reported incident were used during the medical study performed on march 2016 and are not available to perform a failure analysis.Thus, the reported condition of ¿minor skin irritation¿ is unconfirmed.Dhr review; device history record 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 ¿skin irritation and/ or adverse reaction¿ for biopatch product family.Eighteen (19) 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: 7143153
• MDR Text Key: 95728890
• Report Number: 2648988-2017-00069
• 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

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 01/17/2018
• Supplement Dates FDA 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