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

Lot Number	CKDI12-01
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated that opening the product have been difficult, it caused her to drop the items onto a non sterile field yielding them unusable.After following up with customer, it was confirmed that the packaging does not peel apart correctly to keep the item/field sterile.There are 2 needles out of 5 needles experienced not peel apart correctly issue last week alone.
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, production process review and simulated usage procedure, no similar problem was found.On 2024.02.19 5 pieces of 18g×1 1/2"(1.3mm×38mm) needles from retained sample lot no.Ckdi12-01 were sampled from simulated package peelling, no breakage or sticky adhesive was found.After reviewing of the production records, no abnormities were found.Preliminary judgement was the rapid peel-off of the package, video clip or more information is needed for furhter investigation for a thorough investigation, relevant internal report 20240207 could be provided upon request.

• Brand Name: MCKESSON BRANDS
• Common Device Name: NEEDLES
• Manufacturer (Section D): 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: 19266035
• Report Number: 3003560965-2024-00004
• Device Sequence Number: 20582246
• Product Code: FMI
• UDI-Device Identifier: 10612479206554
• UDI-Public: 10612479206554
• Combination Product (Y/N): N
• PMA/510(K) Number: K112057
• 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): 05/04/2024

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
• Operator of Device: Health Professional
• Device Lot Number: CKDI12-01
• 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: 18G×1 1/2"(1.3MM×38MM) NEEDLES LOT NO. CKDI12-01
• Patient Sex: Unknown