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

Catalog Number	201038
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem Description
N/a.
Additional 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
• Common Device Name: 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
• Report Number: 3014334038-2023-00121
• Device Sequence Number: 17623078
• Product Code: HBO
• UDI-Device Identifier: 10381780511632
• UDI-Public: 10381780511632
• Combination Product (Y/N): N
• PMA/510(K) Number: K905433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 201038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown