MAUDE Adverse Event Report: TELEFLEX MEDICAL MALONEY TUNGSTEN FILLED BOUGIE 36F; BOUGIE, ESOPHAGEAL, AND GASTRO

Catalog Number	507936
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "instrument used by date stamp has come off the bougie and cssd are now unable to sterilise as unable to determine correct used by date in accordance with manufacturing guidelines".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4), the sample was returned to the manufacturer for evaluation.The manufacturer reported: "based on the findings during visual inspection to the sample sent, the complaint cannot be confirmed as a manufacturing defect as residue and marks were found from the sealer which is placed over the expiration date to protect the stamping.Additionally, we don't have the enough information about the substance that the customer used to wash the piece.However, manufacturing personnel were notified of this event on may 13, 2024.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported "instrument used by date stamp has come off the bougie and cssd are now unable to sterilise as unable to determine correct used by date in accordance with manufacturing guidelines".No patient involvement reported.

• Brand Name: MALONEY TUNGSTEN FILLED BOUGIE 36F
• Common Device Name: BOUGIE, ESOPHAGEAL, AND GASTRO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19254509
• Report Number: 3004365956-2024-00042
• Device Sequence Number: 17789639
• Product Code: FAT
• UDI-Device Identifier: 14026704642226
• UDI-Public: 14026704642226
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 507936
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown