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 product inside the sterilized package.Another product was used to complete the case.There were no surgical delay greater than 30 min and no adverse consequences to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

Per the creation of (b)(4), the contact reported finding foreign matter (reported as yellow liquid) on the product inside the sterilized package.A 2nd complaint with the same description was created per (b)(4).Seven products were returned with four of them being unopened (for (b)(4)).The product code is 20-1038 (disposable scalp clip applier).The lot code provided was 363631.Upon completion of the investigation, the operators were retrained to mps-pc509.Internal operations were reviewed for the assembling of disposable scalp clip appliers.Per mps-pc509 rev u, 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.In disassembling one of the returned and opened components, an oil track (or drip line) was observed.It was concluded the fluid is the oil lubricant.A procedure exists for the lubrication of the clip sleeve (refer to mps-pc509 rev u).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.The production records for this lot were reviewed and no non-conformances were found.Trends will be monitored for this and similar complaints.At the present time, this complaint is considered closed.

• 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: 3658252
• MDR Text Key: 16600017
• Report Number: 1226348-2014-11285
• Device Sequence Number: 1
• Product Code: HBO
• 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: 03/04/2014
• 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
• 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