MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TTL1LYR 16FR10ML 100%SIL TMP TRAY

Model Number URO170816T

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, "post insertion the foley was leaking." a second foley catheter was reinserted.Email received by (b)(6), critical care supervisor, (b)(6) hospital with additional information in regards to this incident.Reporter states, foley catheter was initially placed (b)(6) 2021 with 10 ml of sterile water.Periodically 2 ml of sterile water would need to be added to the balloon due to urine leakage.Reporter states, (b)(6) 2021 the foley catheter was removed from the patient due to continued leakage.At time of removal, 6 ml of water was found to be in the balloon.A new foley catheter re-inserted without incident or issue of leakage.No report of serious injury.Sample returned for evaluation.Investigation conclusion / root cause: "the reported issue of a leaking foley catheter and inability to remove the retention balloon water could not be confirmed through functional evaluation of the received samples.No further information is available.Due to the reported incident, medical intervention and in an abundance of caution, a medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported, "post insertion the foley was leaking." a second foley catheter was reinserted.

• Brand Name: MEDLINE
• Type of Device: TTL1LYR 16FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11603308
• MDR Text Key: 259012893
• Report Number: 1417592-2021-00065
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866942
• UDI-Public: 10888277866942
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URO170816T
• Device Catalogue Number: URO170816T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/01/2021
• 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): Required Intervention