MAUDE Adverse Event Report: TELEFLEX MEDICAL ESOPHAGEAL BOUGIES; BOUGIE, ESOPHAGEAL, AND GASTRO

Catalog Number 507940

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for investigation.A visual nor functional inspection of the product involved in the complaint could not be conducted since the product was not returned.No additional tests or inspections were conducted since product code 507940 was not in production.A complaint history review was conducted on the catalog number in question from 13-jan-2019 to 20-jan-2020.No complaints were received in this range with the same issue.A device history review could not be conducted since the lot number was not provided.A corrective action could not be conducted due to the lack of product sample and batch number to perform a proper investigation to determine a root cause.Customer complaint cannot be confirmed due to the lack or product sample and batch number to perform a proper investigation and determine a root cause.Teleflex will continue to monitor and trend related events.

Event Description

The report states: at 9am (b)(6) that a bougie had burst inside a patient in the or.Catalog '507940.Bougie with tungsten-filled powder and was expired.Further information indicates the following: no noted change in the patient's condition and no injury.The area was irrigated.The device was being used as a dilator.The expiration date is unknown.

• Brand Name: ESOPHAGEAL BOUGIES
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9621459
• MDR Text Key: 194825202
• Report Number: 3004365956-2020-00017
• Device Sequence Number: 1
• Product Code: FAT
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 507940
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1