MAUDE Adverse Event Report: ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. CARDINAL HEALTH; BLOOD COLLECTION ADAPTER

Lot Number	220725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of customer feedback, personnel from quality, production and other departments were involved in the investigation performed including retained sampling inspection on 2024.03.11, a simulated blood collection sampling procedure as well as the alcohol and iodine compatibility was performed, no abnormity was found.Details are provided below: on 2024.03.11, 20 pieces 20g*19 mm products were sampled from retained sample lot no.220725 for appearance inspection, the transparent package allows observation of the product appearance, and then 10 pcs were sampled from 20 pcs for further simulated clinical blood collection procedure, no adapter breakage was observed, and further inspection were performed for 5 pcs after simulated use for stree cracking test as per iso 594-2, no breakage was found.Based on the customer feedback, the returned pictures were analyzed by the technical personnel who considered it to be relevant with using disinfectant used for the adapter including alcohol, iodine alcohol, three groups of tests were arranged for alcohol wiping, iodine alcohol wiping, and alcohol immersion for 24 hours, no breakage was observed.Further information such as samples returned is needed for the root cause determination, internal report (b)(4) and relevant documents could be provided upon request.
Event or Problem Description
Please find a new complaint attached from a cardinal customer regarding a broken luer hub.Based on the description and lot information provided it appears to be another alcohol-related issue, but we will request additional information on how it was used and what it was used with and share all feedback with you once we receive a response from the customer.

• Brand Name: CARDINAL HEALTH
• Common Device Name: BLOOD COLLECTION ADAPTER
• 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: 19266037
• Report Number: 3003560965-2024-00003
• Device Sequence Number: 6997263
• Product Code: JKA
• UDI-Device Identifier: 10885380182945
• UDI-Public: 10885380182945
• 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
• Operator of Device: Health Professional
• Device Lot Number: 220725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 20GX19MM BLOOD COLLECTION ADAPTER LOT NO. 220725
• Patient Sex: Unknown