MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; MICRO,PUNCTURE,4FR,STIFF,NT/TG,E

Catalog Number	DYNJMAST09
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Provider removed a dilator from right rfa and the "hub came off sheath".
Additional Manufacturer Narrative
It was reported that on (b)(6) 2023, a provider removed a dilator from right rfa and the "hub came off sheath".It was reported that the piece was retrieved and a new device was used to complete procedure.There was no injury reported and no impact to the patient or procedure.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Common Device Name: MICRO,PUNCTURE,4FR,STIFF,NT/TG,E
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; blvd. world trade center no.1; parque industrial oradel; nuevo laredo, tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17419497
• Report Number: 3004122598-2023-00004
• Device Sequence Number: 8901744
• Product Code: OEZ
• UDI-Device Identifier: 10888277586215
• UDI-Public: 10888277586215
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/28/2023

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: DYNJMAST09
• Device Lot Number: 22FBX445
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 07/28/2023
• 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