MAUDE Adverse Event Report: TELEFLEX MEDICAL MALONEY TUNGSTEN FILLED BOUGIE 32F; BOUGIE, ESOPHAGEAL, AND GASTRO

Model Number	IPN029212
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that prior to use it was found that "spots" were found all over the device.No patient involvement.
Event or Problem Description
It was reported that prior to use it was found that "spots" were found all over the device.No patient involvement.
Additional Manufacturer Narrative
Qn # (b)(4).The sample was returned by the customer and sent to the manufacturing site for investigation.The manufacturing site reports "during the visual inspection it can be observed the carton tube show signs of contamination and damage.Also, the bougie have contamination through the body." a device history record review was performed on the lot number of the returned sample and no relevant findings were identified.The manufacturing site conclusion: "per visual inspection results, the condition reported as "spots on the product" cannot be confirmed due the condition in which the material was received.In additional according to the revision of the dhr (device history record) no discrepancies were found on the manufacturing of this product, no tools are used in the manufacturing and inspection process that can generate or be related with the condition reported.The following activities took place: manufacturing personnel were notified of this event on july 25th, 2023." other remarks: n/a corrected data: n/a.

• Brand Name: MALONEY TUNGSTEN FILLED BOUGIE 32F
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17298767
• Report Number: 3004365956-2023-00049
• Device Sequence Number: 6978347
• Product Code: FAT
• UDI-Device Identifier: 14026704642202
• UDI-Public: 14026704642202
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN029212
• Device Catalogue Number: 507932
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/01/2023
• 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