MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML LATEX UM TRAY

Catalog Number URO170216

Device Problem Material Rupture (1546)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported, foley catheter balloon reported to have popped within patient after insertion.Email received by (b)(6), critical care specialist, medline industries, inc., who sent reports received from (b)(6) medical center in regards to the reported incident.Reporter states, (b)(6) year-old, (b)(6), 5'4" female, scheduled for a left percutaneous nephrolithotomy (pcnl procedure) with stent and nephron tube removal.A 16 fr.Silicone-elastomer coated latex foley catheter was inserted for the purposes of draining the bladder immediately after surgery.Reporter states, 7cc of sterile saline from the foley kit was used to fill the foley balloon and secure the balloon in place.Reporter states, upon completion of the procedure the balloon, "was empty and just fell out." reporter states, "re-inserted a single 16 fr.Silicone foley catheter and used bag from kit.Patient discharge (b)(6) 2021." reporter states, no serious injury reported.Due to the reported incident, medical intervention 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.Investigation conclusion / root cause: the reported issue of a deflated foley catheter balloon was confirmed through functional/visual inspection of the received photos.Based on the condition of the samples, some possible root causes could be, but are not limited to, a patient specific condition, insertion method, an error in the manufacturing process, etc.The manufacturing facility will be notified regarding the issue.

Event Description

It was reported, foley catheter balloon reported to have popped within patient after insertion.

• Type of Device: TTL1LYR 16FR10ML LATEX UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 12298103
• MDR Text Key: 268675996
• Report Number: 1417592-2021-00128
• 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: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Date Manufacturer Received: 07/29/2021
• 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
• Patient Age: 60 YR
• Patient Weight: 55