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

Catalog Number 245404

Device Problem Component Missing (2306)

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

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 they found 9 patties instead of 10 in the box during table setup.The procedure was completed with a replacement product available.No patient injury.

Manufacturer Narrative

Unique device identification (udi): (b)(4).The surgical patties were returned for evaluation: device history record (dhr) - the lot number for the product was not reported and could not be determined from the returned product.Therefore, a manufacturing record review is not possible.Failure analysis - the pattie/strip unit was inspected using the unaided eye.The complaint report of 9 patties was confirmed.The complaint could be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation confirmed the complaint.However, because this product is made on two different types of machines (automatic or hybrid) it is not possible to determine the root cause since it cannot be determined which machine this specific pattie was made on.If these patties were made on an automatic machine, then the root cause would be the machine not detecting the count being incorrect.If it were made on a hybrid machine, the root cause would be operator error since the operator would have been the one to miss the count of patties.To determine which is the actual root cause, the lot number would need to be known so it could be known which type of machine the product was manufactured.A corrective action is currently open to investigate the patties/strips product family.

Event Description

N/a.

• Brand Name: BULK SURG PAT 1/2 X 1/2
• Type of Device: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12250488
• MDR Text Key: 264284779
• Report Number: 3014334038-2021-00154
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 245404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1