MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. MCKESSON BRANDS; NEEDLE HOLDER

Lot Number	CKDB11-01
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Per customer, the needle does not lock in place.
Additional Manufacturer Narrative
Upon receipt of customer complaint, personnel from quality, production and other relevant departments were involved in the investigation including retained sample inspection, simulated usage procedure, no similar problem was found.On 2024.02.19 5 pieces of needle holders were sampled from retained samples from lot no.Ckdb11-01, and by means of simulated clinical procedure, no similar reported problem was identified.Through abovementioned investigation, and based on the customer feedback.More information is needed for furhter investigation and it would be better if the exact defective device could be delivered back to us.Relevant internal report 20240205 and video clip for simulated clinical use could be provided upon request.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758, 5th binhai road; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer (Section G): ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.; no. 758 5th binhai road; wenzhou, zhejiang 32502 5; CH 325025
• Manufacturer Contact: suhua li ; no. 758 5th binhai road; wenzhou, zhejiang 32502-5 ; CH 325025
• MDR Report Key: 19266033
• Report Number: 3003560965-2024-00002
• Device Sequence Number: 12511812
• Product Code: JKA
• UDI-Device Identifier: 20612479244461
• UDI-Public: 20612479244461
• Combination Product (Y/N): N
• PMA/510(K) Number: K172763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2024

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 Lot Number: CKDB11-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NEEDLE HOLDER, LOT NO. CKDB11-01
• Patient Sex: Unknown