MAUDE Adverse Event Report: UNKNOWN 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 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide a lot number allowing for identification of the manufacturer.

Event Description

It was reported that foreign mater was noted when using the syringe to draw up an iv push antibiotic dose.No information was received regarding any type of serious injury as a result of this product malfunction.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE, LL 60CC
• Manufacturer (Section D): UNKNOWN; CH
• MDR Report Key: 15313710
• MDR Text Key: 298876307
• Report Number: 1451040-2022-00049
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 102-S60C
• 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: 08/29/2022
• Distributor Facility Aware Date: 08/03/2022
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1