MAUDE Adverse Event Report: RAYNHAM SCALP CLIP APPLIER DISPOSABLE; N/A

Catalog Number 201038

Device Problem Material Discolored (1170)

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

Event Date 07/07/2023

Event Type  malfunction  

Event Description

A facility reported one of the 10 packs of unopened scalp clip disposable (id 201038) has a brown dot.The issue was detected before the surgery.The procedure was completed with a replacement product available.No patient injury reported, and the event did not led to surgical delay.Based on the information provided, it is unknown if the product was stored in its original packaging, in its original pouch, or original dispenser box.It is also unknown how was the product stored.

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

N/a.

Manufacturer Narrative

Scalp clip disposable (id 201038) was returned for evaluation.Device history record (dhr) - no anomalies occurred during the manufacturing process.Failure analysis - in the failure analysis that was performed, the returned unit was found to have the brown dot.Root cause analysis - the likely root cause is a residue present at the time of molding the parts of the applier.

• Brand Name: SCALP CLIP APPLIER DISPOSABLE
• Type of Device: N/A
• 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: 17406845
• MDR Text Key: 319899409
• Report Number: 3014334038-2023-00121
• Device Sequence Number: 1
• Product Code: HBO
• UDI-Device Identifier: 10381780511632
• UDI-Public: 10381780511632
• Combination Product (y/n): N
• PMA/PMN Number: K905433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2022
• 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