MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TOTAL JOINT-CENTURA HEALTH-LF

Catalog Number DYNJCEN19D

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/13/2024

Event Type  Injury  

Manufacturer Narrative

According to the facility "30 ml syringes have been having the finger tabs on them breaking off while attempting to use".Per the facility "this happened while we had patients open on the table, with staff and surgeon able to collect all pieces prior to wound closure".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

According to the facility "30 ml syringes have been having the finger tabs on them breaking off while attempting to use".

• Type of Device: TOTAL JOINT-CENTURA HEALTH-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18867665
• MDR Text Key: 337242651
• Report Number: 1423395-2024-00342
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 10193489397710
• UDI-Public: 10193489397710
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJCEN19D
• Device Lot Number: 23LBI223
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other