MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY TTL VENT 100%SILI UM 16FR

Catalog Number URO180816S

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was initially reported that the foley catheter was found disconnected with the drainage bag tubing, with the yellow tamper seal still intact.It was added that the patient's foley catheter had to be replaced.Despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.Due to the reported incident and the required foley catheter exchange, this medwatch is being filed.The sample has been returned for evaluation.The reported issue of the catheter disconnecting from the drainage bag tubing was confirmed through visual inspection of the received sample.The suspected root cause is an assembly error in the kit packing process having not inserted the tubing adapter adequately into the funnel.Changes to the assembly instructions were implemented to address concerns of catheters disconnecting from drainage bag tubing at the yellow tamper seal.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that a foley catheter exchange was required after foley catheter was found disconnected with the drainage bag tubing, with the tamper seal still intact.

• Type of Device: TRAY TTL VENT 100%SILI UM 16FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 9412573
• MDR Text Key: 190769521
• Report Number: 1417592-2019-00218
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10889942767038
• UDI-Public: 10889942767038
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO180816S
• Device Lot Number: 96919020001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2019
• 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