MAUDE Adverse Event Report: SUZHOU LINHWA MEDICAL DEVICES CO,LTD MCKESSON BRANDS; SYRINGE, LL 60CC

Catalog Number 102-S60C

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

Customer reported that there was a hair inside of the syringe.No information was received regarding any serious injury as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE, LL 60CC
• Manufacturer (Section D): SUZHOU LINHWA MEDICAL DEVICES CO,LTD; no.3, weixin road; suzhou industrial park, 21512 1; CH 215121
• MDR Report Key: 16656986
• MDR Text Key: 312496737
• Report Number: 1451040-2023-00016
• 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: 03/31/2023,03/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 102-S60C
• Device Lot Number: CLNB07-01
• 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: 03/31/2023
• Distributor Facility Aware Date: 03/15/2023
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/31/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1