MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; IV ADMIN SET, SECONDARY, 40" W / HANGER

Model Number DYNDTA1540

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2023

Event Type  malfunction  

Manufacturer Narrative

According to the customer between (b)(6) 2023, the secondary set is "breaking up" at the luer lock adapter when administering antibiotics and hooked to a primary line.It was reported that the "tip either breaks right away or breaks during infusion" when giving cleocin iv and "leaking the medication into the floor".Customer reports using clindamycin phosphate in 0.9% sodium chloride injection 50ml.The customer reports when the event was noticed, the infusion was stopped immediately and the product was removed from use.The customer reports no injuries, medical intervention or follow up care due to the reported incident.A sample was 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

Medication leaking from iv set.

• Brand Name: Medline
• Type of Device: IV ADMIN SET, SECONDARY, 40" W / HANGER
• 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: 16591831
• MDR Text Key: 311835720
• Report Number: 1417592-2023-00128
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10888277655881
• UDI-Public: 10888277655881
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/22/2023

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 Model Number: DYNDTA1540
• Device Catalogue Number: DYNDTA1540
• Device Lot Number: 0332205A07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/22/2023
• 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