MAUDE Adverse Event Report: BD DURASAFE¿ TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 400713

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the catheter from the bd durasafe¿ tray fractured apart at the beginning of the epidural procedure and remained inside the patient.Most of the broken pieces were possible to remove; although images were performed, the remaining fragment could not be found.The following information was provided by the initial reporter, translated from spanish to english: "when inserting the catheter, it fractured.The event occurred during the placement of the catheter for epidural anesthesia." "it was further reported that the catheter broke inside the patient, and it was only possible to remove a part of it.At this time, the patient doesn't know that there is a fragment inside of her, image exams couldn't find where the fragment is located, and they want to know if it or its components are biodegradable or if the presence of the fragment inside the patient could represent a threat of danger to health.-was there any health impact to patient? r: at this time, there are no events that could suggest any situation, however there is the doubt if a time from now it could represent a danger of damage to patient.Until (b)(6) 2021, the hospital didn't know if the patient has been communicated that the fragment is inside of her.Was there any medical intervention required? r: they have performed exams of image in an attempt to find the fragment localization, however it hasn't been located.Was there exposure to blood or bodily fluids? is the physical sample available available for evaluation? r: no, the device broke at the beginning of the procedure.".

Event Description

It was reported that the catheter from the bd durasafe¿ tray fractured apart at the beginning of the epidural procedure and remained inside the patient.Most of the broken pieces were possible to remove; although images were performed, the remaining fragment could not be found.The following information was provided by the initial reporter, translated from spanish to english: "when inserting the catheter, it fractured.The event occurred during the placement of the catheter for epidural anesthesia." "it was further reported that the catheter broke inside the patient, and it was only possible to remove a part of it.At this time, the patient doesn't know that there is a fragment inside of her, image exams couldn't find where the fragment is located, and they want to know if it or its components are biodegradable or if the presence of the fragment inside the patient could represent a threat of danger to health.Was there any health impact to patient? r: at this time, there are no events that could suggest any situation, however there is the doubt if a time from now it could represent a danger of damage to patient.Until (b)(6) 2021, the hospital didn't know if the patient has been communicated that the fragment is inside of her.Was there any medical intervention required? r: they have performed exams of image in an attempt to find the fragment localization, however it hasn't been located.Was there exposure to blood or bodily fluids? is the physical sample available available for evaluation? r: no, the device broke at the beginning of the procedure.".

Manufacturer Narrative

H.6.Investigation: a complaint of a catheter breaking during placement was received from the customer.A sample was provided to aid in the investigation of this defect.Through sample evaluation, the customer complaint was verified.During evaluation, the needle was inspected and no defects were found.The needle was then tested with new catheters to see if the needle could cause the failure but no issues were detected.The catheter was then inspected and damage could be seen on the catheter.The damaged was caused by a sharp instrument/ material.A device history record review was completed by our quality engineer team for provided lot number 0282424.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.The root cause was determined not to be related to the manufacturing process.This is the first complaint for catheter broken during/ after use on material 400713 & batch 0282424.

• Brand Name: BD DURASAFE¿ TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11530834
• MDR Text Key: 243472664
• Report Number: 2618282-2021-00017
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 400713
• Device Lot Number: 0282424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2020
• 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
• Patient Outcome(s): Required Intervention