MAUDE Adverse Event Report: RAYNHAM BULK SURG PAT 1/2 X 3; OEM PATTIES & STRIPS

Catalog Number 245411

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported hair in the pack of surgical patties.The incident happened while setting up for the procedure.No patient injury reported.The product was stored in its original packaging in the hospital supply room.

Manufacturer Narrative

The surgical pattie was not returned for evaluation but a photo was provided showing the hair present on the patties.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the pattie/strip unit was inspected using the unaided eye.The hair was present on the photo provided by the customer.The complaint could be verified through failure analysis.Hair in contact with product confirmed.Product is made on a hybrid machine where an operator manually wraps the product on the card.The product is then manually placed in a sealer.The operations are performed in a iso class 8 cleanroom.The requirements for this environment include a hair-net and gown with long sleeves.The hair contaminating the product appears to be the type which would be contained by the hairnet.Hair contamination occurred during one of these two steps due to improper concealment of hair in hair net.Applicable operators will be retrained to hair gowning procedure.

Event Description

N/a.

• Brand Name: BULK SURG PAT 1/2 X 3
• Type of Device: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12374477
• MDR Text Key: 268371610
• Report Number: 3014334038-2021-00179
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 245411
• Device Lot Number: 5140349
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1