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

Catalog Number 201038

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The scalp clip was returned for evaluation: dhr - no anomalies were recorded in the dhr record.Failure analysis - the returned unit does not work as intended, a hair was observed within the blister packaging.The complaint could be verified through failure analysis root cause - the complaint was confirmed in the complaint investigation, the hair within the packaging was confirmed.A 6m root cause analysis was performed, and the following areas were examined: man, method, machine, materials, measures and mother nature.Upon examination of those areas, it is determined that the root cause likely lies within ¿man¿.The operators manually place the units within the blister packaging, then they are loaded into the machine that seals the packaging.Operators are required to wear hair nets and gown in the environment where the packaging takes place.Failure analyst states that the hair found appears to be one which would be contained by a hair net.The operator(s) will be retrained on the procedure.

Event Description

It was reported hair material was found inside the package when the package was inspected at the distributor's inspection room.No patient contact/injury reported.

Manufacturer Narrative

Previous report with (product description) referenced a "shoulder, slide battery".The field has been updated to "scalp clip applier disposable".To match the product id 201038.

Event Description

N/a.

• Brand Name: SCALP CLIP APPLIER DISPOSABLE
• Type of Device: N/A
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: vivian nelson ; 325 paramount drive; raynham, MA 02767 ; 6099362319
• MDR Report Key: 10486207
• MDR Text Key: 209208836
• Report Number: 3014334038-2020-00032
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• PMA/PMN Number: K905433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 201038
• Device Lot Number: J5400J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• 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