MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYR 6FR1.5ML 100%SILI PEDS TR

Catalog Number	DYND160806
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
"balloon would not deflate.".
Additional Manufacturer Narrative
It was reported by the customer contact that on (b)(6) 2023, "balloon would not deflate".It was reported that due to this "the patient (a 5 month old), need another procedure to be done to go back in, and pop the balloon".No injury was reported related to the incident.A sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: 1LYR 6FR1.5ML 100%SILI PEDS TR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18312483
• Report Number: 1417592-2023-00495
• Device Sequence Number: 6718553
• Product Code: OHR
• UDI-Device Identifier: 10884389118900
• UDI-Public: 10884389118900
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/12/2023

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?: No
• Device Catalogue Number: DYND160806
• Device Lot Number: 592220105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown