MAUDE Adverse Event Report: SUZHOU LINHWA MEDICAL DEVICES CO,LTD MCKESSON BRANDS; SYRINGE STR 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 10/05/2021

Event Type  malfunction  

Event Description

The customer reported that the syringe was removed from the wrapper and a hair was observed inside of the barrel.No information was received regarding any serious injury as a result of this report.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE STR LL 60CC
• Manufacturer (Section D): SUZHOU LINHWA MEDICAL DEVICES CO,LTD; no.3, weixin road; suzhou industrial park; suzhou, 21512 1; CH 215121
• MDR Report Key: 12696343
• MDR Text Key: 282039207
• Report Number: 1451040-2021-00023
• 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: 10/26/2021,10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• 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: CLNA06-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2021
• Distributor Facility Aware Date: 10/05/2021
• Device Age: 4 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other