MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; 1LYR 16FR10ML 100%SIL TMP SAFE

Catalog Number URO170816TQ

Device Problem Material Rupture (1546)

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

Event Date 03/27/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023, the rn inserted the foley catheter, "noticed urine immediately started flowing around the catheter", and when the patient was repositioned the catheter "fell out" due to the balloon being "ruptured".The customer reported an additional catheter was required to be inserted.The customer reported there was no serious injury related to the reported event.Sample was requested for return evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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 customer, on (b)(6) 2023, the rn inserted the foley catheter, "noticed urine immediately started flowing around the catheter", and when the patient was repositioned the catheter "fell out" due to the balloon being "ruptured".

• Type of Device: 1LYR 16FR10ML 100%SIL TMP SAFE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16808302
• MDR Text Key: 313938017
• Report Number: 1417592-2023-00186
• Device Sequence Number: 1
• Product Code: OHR
• 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: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: URO170816TQ
• Device Lot Number: 23ABI773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2023
• 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