MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTLVENT 16FR10ML 100%SIL UM TR

Catalog Number URO180816

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/04/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the foley catheter broke off and had to be surgically removed.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, or incident details to the manufacturer.The sample was received in used, unpackaged condition.The reported issue of a broken foley catheter was confirmed through visual inspection of the received sample, through the presence of a cut across the shaft and a tear in the balloon.There is no definitive root cause for the tears at this time.However, based on the appearance of the received sample, it is suspected that an external force punctured the silicone material, leading to the observed tears.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

It was reported that the foley catheter broke off and had to be surgically removed.

• Type of Device: TTLVENT 16FR10ML 100%SIL UM TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 8569166
• MDR Text Key: 143701882
• Report Number: 1417592-2019-00062
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10889942687145
• UDI-Public: 10889942687145
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO180816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: 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