MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. RANEY SCALP CLIP FCPS; CLIPS, SCALP

Catalog Number 20-5115

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

As reported by the ous affiliate, dust was found in a sealed pack of raney forceps during the product inspection.Occurred before use on patient.As reported by the ous affiliate, the contamination was reported inside the sterile barrier.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the returned instrument was returned inside the original closed plastic bag.Evaluation of the returned product confirmed the complaint; there is loose foreign material (black specks) inside the plastic bag.However, this instrument is a non-sterile product and is sterilized prior to use on patient.Therefore; the particulates would not cause harm to the patient.The package (containing the particles) is open and discarded prior to sterilizing the instrument for use.If there are any particles on the instrument it is likely particles would be removed during the hospitals sterilization process.The complaint of ¿dust was found in a sealed pack of raney forceps" was confirmed and is associated with packaging processes.It appears that this product was packaged in (b)(4).The packaging team ((b)(4) facility) was notified of this complaint and photos were submitted for review.Based on the results of this investigation, no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: RANEY SCALP CLIP FCPS
• Type of Device: CLIPS, SCALP
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6286583
• MDR Text Key: 66360252
• Report Number: 1226348-2017-10071
• Device Sequence Number: 1
• Product Code: HBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20-5115
• Device Lot Number: 1182012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1