MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; LUER LOCK ACCESS DEVICE

Model Number ACSD

Device Problem Break (1069)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/14/2023

Event Type  Injury  

Event Description

Device broke while connected to iv requiring new iv site to be placed.

Manufacturer Narrative

The customer reported that the device broke while "connected to the end of an iv".According to the customer, due to this the iv was pulled and a new iv was placed.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.

• Brand Name: Medline
• Type of Device: LUER LOCK ACCESS DEVICE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16913949
• MDR Text Key: 315032413
• Report Number: 1417592-2023-00212
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 10193489006070
• UDI-Public: 10193489006070
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ACSD
• Device Catalogue Number: ACSD
• Device Lot Number: (10)220720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other