MAUDE Adverse Event Report: RAYNHAM RANEYSCLP CLP DSPOSE -200; SCALP CLIPS

Model Number 201037

Device Problem Contamination (1120)

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

Event Date 08/08/2022

Event Type  malfunction  

Event Description

A facility reported the scalp clips (id (b)(6)) had a hair mixed-in, and the inner bag was caught in the seal part of the outer bag.The product was stored in its original pouch.No patient injury/involvement reported.

Manufacturer Narrative

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

Manufacturer Narrative

Scalp clips ( id- 201037) was returned for evaluation.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- visual inspection confirmed the presence of a hair in one of the product bags.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (dhr) review and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the dhr.Product was received for analysis and the investigation could confirm the complaint condition.

• Brand Name: RANEYSCLP CLP DSPOSE -200
• Type of Device: SCALP CLIPS
• 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: 15410429
• MDR Text Key: 299769032
• Report Number: 3014334038-2022-00202
• Device Sequence Number: 1
• Product Code: HBO
• UDI-Device Identifier: 10381780511625
• UDI-Public: 10381780511625
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2023

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 Model Number: 201037
• Device Catalogue Number: 201037
• Device Lot Number: BP607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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