MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; SYRINGE/NDL LL 3CC 25GX5/8"

Catalog Number 16-SN3C2558

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/13/2021

Event Type  malfunction  

Event Description

The customer reported that the needles bend and that they are having trouble getting them through stoppers to draw up injectables and sometimes go through a couple just to draw up an injection.They reported a needle stick following recapping.It was also reported that the needles leak from the side.No information was received regarding any serious injury.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE/NDL LL 3CC 25GX5/8"
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 12369860
• MDR Text Key: 268210370
• Report Number: 1451040-2021-00014
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-SN3C2558
• Device Lot Number: CKDJ10-04
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2021
• Distributor Facility Aware Date: 08/13/2021
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other