MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY,FOLEY,SILVER,2-WAY,16FR,10ML,LF

Catalog Number	DYND140216
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that on (b)(6) 2019, during placement of an indwelling catheter, the balloon that was placed in the patient ruptured within a few minutes of the balloon being inflated.After the balloon ruptured the catheter slid out and a new catheter insertion was required.The facility reported that prior to the initial catheter insertion the balloon of the catheter was pre-inflated to check the integrity of the balloon prior to insertion, contrary to the manufacturer's instructions for use.The patient did not require any surgical intervention after the reported incident.The facility reported that there was no serious injury identified, medical intervention required, or follow-up care needed.There was no change to the patient's plan of care and the patient has since been discharged from the hospital without incident.The actual device involved in the reported incident was returned for evaluation.The reported issue of a burst balloon was confirmed through visual inspection of the received sample.There is no definitive root cause for the tear at this time; however, based on the break pattern, it is suspected that the burst was caused by internal pressure within the balloon rather than an external force.There was no serious injury, follow-up medical care or additional medical intervention required related to the incident, however medical intervention to replace the initial catheter was necessary.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 or Problem Description
It was reported that during placement of an indwelling catheter the balloon that was placed in the patient ruptured within a few minutes of the balloon of the catheter being inflated.A new urinary catheter was required to be inserted.

• Common Device Name: TRAY,FOLEY,SILVER,2-WAY,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8575338
• Report Number: 1417592-2019-00053
• Device Sequence Number: 18893415
• Product Code: OHR
• UDI-Device Identifier: 10080196183418
• UDI-Public: 10080196183418
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND140216
• Device Lot Number: 19ABK969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 86