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

Model Number IPN029212

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that prior to use it was found that "spots" were found all over the device.No patient involvement.

Event Description

It was reported that prior to use it was found that "spots" were found all over the device.No patient involvement.

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
• Type of Device: 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
• MDR Text Key: 319065659
• Report Number: 3004365956-2023-00049
• Device Sequence Number: 1
• Product Code: FAT
• UDI-Device Identifier: 14026704642202
• UDI-Public: 14026704642202
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1