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

Catalog Number 20-1037

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For p/c 801400- patties:samples were not returned therefore evaluation to confirm miscount could not be completed.A dhr review was completed and no errors were found.Manufacturing documentation was reviewed for any variations in current process and no variations were found.Lot number was sent in with the sample (lot number ha8252) for p/c 201037 raney clips: the manufacturer was notified of the complaint of "miscount".The product was not returned; therefore, the reported " raney clip miscount" could not be verified.Dhr review for both lots reported ak605 and dk653, there were no manufacturing defects noted during the manufacturing process.We will continue to monitor for this or similar complaints for these product codes.At this time tis complaint is considered to be closed.Device not available.

Event Description

As reported by the ous affiliate, a package of codman patties 10-pack contained 11patties, a codman rainey clip 10-pack contained 21 clips and another codman rainey clip 10-pack contained 11 clips.Once count was done, hospital discarded extra products in packages and continued procedure.There were no reports of delay or patient harm.

Manufacturer Narrative

Device was returned for evaluation.A follow up report will be filed upon completion of the investigation.Supplier response for the raney clips: we have implemented additional piece count checks for this area throughout time, the 21 count is the one that is tougher to connect with a true root cause.The dhr folders have been reviewed with no indication of miss-counts being recorded.

Manufacturer Narrative

The device was returned for evaluation.Received were two open packets of surgical patties and 21 individual clips.Each pack should contain 10 clips.Based on the package being opened upon receipt, we are unable to conclusively determine at what point the reported issue may have occurred.Additionally, we can only confirm that one extra clip was present in the two packets.We are unable to determine which packet contained the additional clip.A dhr review for the reported lots found no manufacturing defects during the manufacturing process.Based on the information available, it appears that a device failure has occurred; however, the supplier was not able to determine root cause.The supplier has implemented additional piece count checks.Trends will be monitored for this and similar complaints.At present, we consider this complaint to be closed.Refer to mdr 1226348-2017-10885 for information regarding the second product received with this one.

• Brand Name: RANEY SCALP CLIPS
• 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: 7060063
• MDR Text Key: 93581659
• Report Number: 1226348-2017-10884
• 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,Followup

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 Catalogue Number: 20-1037
• Device Lot Number: AK605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/27/2017
• Supplement Dates Manufacturer Received: 01/16/2018; 02/16/2018
• Supplement Dates FDA Received: 01/31/2018; 02/16/2018
• 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