MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; NEEDLE HYPO RW 30GX1/2"

Model Number 16-N3005

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

All the returned samples had been evaluated and found no sealing and loosening defectives in the luer lock component of needle.However, from the five returned samples used, we found that four needles were blocked.The production process of the needle had been reviewed, and we found that the assembly equipment of the needle was repaired on the time due to a gas leak in the air pipe.And we checked the products produced before repaired, and no blocked products were found.The four blocked needles had been analyzed, and we concluded that the blocked needle from the material.We informed the supplier to request an investigation of the needle and perform capa.The current production process also investigated and reviewed, and no information showed that the current production process may produces blocked needles.A device history record review was completed for these lot numbers, no defects or imperfections were observed.

Event Description

The customer reported that several needles have been defective as they are not staying attached to the syringe.In some cases,they have experienced needles that they could not push medicine through.The luer lock component of the needle does not seal properly and is loose causing the needle to pop off during injection.Customer reported using lidocaine,clindamycin,bupivacaine,and sodium bicarb with the needles.No information was received regarding any serious injury as a result of this product malfunction.

• Brand Name: MCKESSON BRANDS
• Type of Device: NEEDLE HYPO RW 30GX1/2"
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no.23 huanxi rd,zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• MDR Report Key: 16045720
• MDR Text Key: 308537674
• Report Number: 3005670221-2022-00002
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172938
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16-N3005
• Device Catalogue Number: 16-N3005
• Device Lot Number: CJCA05-01,CJCA07-01,CJCA08-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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
• Patient Outcome(s): Other