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

Catalog Number 20-1037

Device Problems Component Missing (2306); Incorrect Device Or Component Shipped (2962)

Patient Problem No Information (3190)

Event Date 08/03/2017

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, during surgery, the nurse opened 3 packs and found out there are 29pc in total instead of 30pc.Later on, same lot from different boxes were inspected and it was found that there is 11 pc in one of the packs from another box with same lot.There were no reports of delays; to resolve the issue, another pack was opened.

Manufacturer Narrative

Upon completion of the investigation it was noted that the received 29 raney clips in a plastic bag, 3 labels from original packages and 1 unopened package with 11 clips.All returned clips/labels were from lot# fg613.The 29 clips were not in the original package; therefore, it is not possible to determine how many were in the individual package.Pictures of the returned clips were forwarded to the supplier.The complaint of "miscounts" was confirmed and is attributed to manufacturing/supplier error.Note: internal supplier quality engineer was made aware of complaints regarding miscounts for this product code.No product from this lot is in inventory (produced & shipped september, 2014).True root cause is unknown due to the manufacturing time of the product.Several piece count verifications were within the process with several added over the past few years.Additional scale/piece checks were added to the job instructions: production to verify piece counts on the bagger scale two times/shift and quality to verify piece counts two times/shift using the second piece count scale.Increased lot inspection of the bagged clips to 200 bags/tote.Continued awareness to team members for heightened inspection of the product along with all the above.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 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: 6795013
• MDR Text Key: 82779782
• Report Number: 1226348-2017-10612
• 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: foreign
• 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

• 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: FG613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/15/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 09/05/2017
• 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