DRAPE, ADHESIVE, SEROSOL
Received Oct 12, 2020 · Event occurred Aug 25, 2020
Report 1000306225-2020-00008 · MDR key 10667484
Device
Product problems
- Device Misassembled During Manufacturing /Shipping
- Manufacturing, Packaging or Shipping Problem
- Component Misassembled
- Device Misassembled During Manufacturing /Shipping
- Manufacturing, Packaging or Shipping Problem
- Component Misassembled
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
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
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.