MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; TTL1LYR 16FR10ML 100%SILI DB TRA

Model Number URO170716

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 06/18/2022

Event Type  Injury  

Manufacturer Narrative

According to the facility a foley catheter was placed on (b)(6) for urinary retention.Per the facility the following day the patient felt a 'pop' and the foley catheter came out, requiring a replacement catheter.Per the facility the balloon had a slit on the side.According to the facility the balloon was not tested prior to inflation, but the catheter was placed without difficulty and the balloon was inflated with 10ml's of normal saline and secured to the patient's leg.The device is not available to be returned for evaluation as it was discarded.No additional information is available.Due to the reported incident and 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 a foley catheter was placed on (b)(6) for urinary retention.Per the facility the following day the patient felt a 'pop' and the foley catheter came out, requiring a replacement catheter.

• Brand Name: Medline
• Type of Device: TTL1LYR 16FR10ML 100%SILI DB TRA
• 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: 15058712
• MDR Text Key: 296210998
• Report Number: 1417592-2022-00106
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866911
• UDI-Public: 10888277866911
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URO170716
• Device Catalogue Number: URO170716
• Device Lot Number: 21IBQ760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• 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): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 84 KG