MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. CODMAN DISPOSABLE SCALP CLIP APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number 20-1038

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

Patient Problem No Code Available (3191)

Event Date 02/24/2014

Event Type  malfunction  

Event Description

The affiliate reported: it was reported that the foreign matter (reported as yellow liquid) had been found on the products inside the sterilized package.The same complaint had already been reported as com-041056 (co20140086) and this is second detection from the stock at the same facility.There were no surgical delay greater than 30 min and no adverse consequences to the patient.(b)(4) 2014 additional information from the affiliate stated: as for your inquiry, all 9 pieces were found from the inventory at the hospital.

Manufacturer Narrative

Upon completion of the investigation, a follow up report will be filed.

Manufacturer Narrative

Upon completion of the investigation it was noted that the operators were made aware of the complaint and retrained to (b)(4).A previous complaint with the same description was created per (b)(4).Nine products were returned (for (b)(4)).The product code is 20-1038.The lot codes provided were 363631, 338524, and 379505.The production records for these lots were reviewed and no non-conformances were found.Internal operations were reviewed for the assembling of disposable scalp clip appliers.The use of an oil lubricant is permitted.For lot code 363631, a yellow spot was seen on the tyvek lid and on the tip of the clip applier.Manual operation includes placing three drops of oil in the indicated area.The root cause can most likely be attributed to human error as the lubrication process is a manual operation.Upon disassembling one of the returned products, a trail of oil was found along the entire length of the device, originating from the clip sleeve.An excessive amount of oil was added to the product and ultimately contributed to the runoff of oil.Any additional complaints will be monitored.No further actions are required.At the present time, this complaint is considered closed.

Event Description

Additional information stated; note that all nine returned products are new/never used/never opened.

• Brand Name: CODMAN DISPOSABLE SCALP CLIP APPLIER
• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 3677483
• MDR Text Key: 4295043
• Report Number: 1226348-2014-11311
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• 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: 03/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20-1038
• Device Lot Number: 363631;338524;379505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2014
• 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