MAUDE Adverse Event Report: SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO MCKESSON BRANDS; SYRINGE, LL 5CC

Catalog Number 16-S5C

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported by the customer that the syringe cracked along the barrel during an injection of a viscous medication into the joint causing the medication to leak out.No information was received regarding any serious injury as a result of these reported issues.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE, LL 5CC
• Manufacturer (Section D): SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO; no. 658, gao chao rd., jiading; shanghai, shanghai 20180 3; CH 201803
• MDR Report Key: 16807103
• MDR Text Key: 313921078
• Report Number: 1451040-2023-00019
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/25/2023,04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-S5C
• Device Lot Number: CKDB06-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2023
• Distributor Facility Aware Date: 04/05/2023
• Device Age: 10 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1