MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X1 1/2; SURGICAL PATTIES

Model Number 801404

Device Problem Contamination (1120)

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

Event Date 08/24/2021

Event Type  malfunction  

Manufacturer Narrative

The surgical pattie was not returned for evaluation but a photo was provided showing the hair present on the patties.The complaint could be verified through failure analysis.Root cause: 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.Dhr: there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.

Event Description

A distributor reported the surgical pattie was sealed with a hair inside.Issue was detected during inspection at the distribution site.

• Brand Name: SURG PAT XRAY 1/2X1 1/2
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 12512493
• MDR Text Key: 272690876
• Report Number: 3014334038-2021-00198
• Device Sequence Number: 1
• Product Code: HBA
• UDI-Device Identifier: 10381780515005
• UDI-Public: 10381780515005
• 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,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 801404
• Device Catalogue Number: 801404
• Device Lot Number: 5140452
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Date Device Manufactured: 02/18/2021
• 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