FDA Adverse Event Malfunction Summary report: N

DRAPE, ADHESIVE, SEROSOL

MDR report key: 10667484 · Received October 12, 2020

Report

Report Number: 1000306225-2020-00008
Event Type: Malfunction
Date Received: October 12, 2020
Date of Event: August 25, 2020
Report Date: September 23, 2020
Manufacturer: NOVO HEALTH SERVICES
Product Code: KGT
UDI-DI: 00810019001082
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2020, THE END-USER REPORTED THAT THEY NOTICED THAT THE REUSABLE SPLIT DRAPE ADHESIVE TAPE WAS NOT APPLIED CORRECTLY AFTER THE SURGICAL PROCEDURE. THE TAPE AREAS DIDN'T COME IN CONTACT WITH THE DRAPE LEFT POCKETS FOR POTENTIAL CONTAMINATION CONCERNS. A PICTURE OF THE REUSABLE SPLIT SHEET, AND THE ADHESIVE TAPE WAS EMAILED TO THE CLIENT RELATIONS REP; NO PRODUCT WAS RETURNED. BASED ON THE PICTURE, THE FACILITY TOOK THE FOLLOWING ACTIONS: THE CORPORATE QA/RA REVIEWED THE POLICIES AND PROCEDURES. THERE WERE NO CHANGES MADE. VERIFIED THE EXPIRATION DATE FOR THE ADHESIVE TAPE (MAY 2023). INFORMED APPROPRIATE STAFF MEMBERS OF THE COMPLAINT AND POSSIBLE OUTCOMES. PROVIDED REFRESHER TRAINING, AND VERIFIED EFFECTIVENESS THROUGH IN-PROCESS INSPECTIONS. REVIEWED PAST DATA FOR ANY TRENDING ISSUES/CONCERNS, NONE NOTED. THE DOCTOR DID NOT CHANGE THE CLASSIFICATION OF SURGERY, NOR PROVIDE ANY ADDITIONAL THERAPIES/STEPS. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

THE END USER REPORTED THAT THE ADHESIVE TAPE (ITEM #32) WAS NOT PLACE CORRECTLY ON THE REUSABLE SPLIT SHEET (ITEM #3720). THE DRAPE WOULD NOT ADHERE CORRECTLY THEREFORE, A STERILE BARRIER WAS NOT ACHIEVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1131586	DRAPE, ADHESIVE, SEROSOL	DRAPE, ADHESIVE	KGT	NOVO HEALTH SERVICES	32		00810019001082

Patients

Seq	Age	Sex	Outcome	Treatment
1