MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE, LUER LOCK, STERILE, 30ML

Catalog Number SYR130010

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer "flange broke off into patients wound.Doctor was able to retrieve broken piece".No additional details were available related to the incident.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Flange broke off syringe.

• Type of Device: SYRINGE, LUER LOCK, STERILE, 30ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield, il 60093 ; MX 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18444900
• MDR Text Key: 331906513
• Report Number: 1417592-2024-00005
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10080196310234
• UDI-Public: 10080196310234
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: SYR130010
• Device Lot Number: 230405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other