MAUDE Adverse Event Report: BD ANESTHESIA KIT DURASAFE¿

Catalog Number 400713

Device Problems Break (1069); Leak/Splash (1354); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.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 during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.

Manufacturer Narrative

The following fields have been updated with additional information: b.5.Describe event or problem: it was reported that during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.Additionally the customer provided the following additional information: the packaging of the material and therefore, as there is no certainty of the integrity of the product.We proceeded to return it to the central pharmacy and not use it on the patient.Another material was used.No damage.F.10 device codes: 3007.

Event Description

It was reported that during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.Additionally the customer provided the following additional information: the packaging of the material and therefore, as there is no certainty of the integrity of the product.We proceeded to return it to the central pharmacy and not use it on the patient.Another material was used.No damage.

Event Description

It was reported that during use it was discovered the epidural catheter was damaged with a bd anesthesia kit durasafe¿.The following information was provided by the initial reporter, translated from portuguese to english: when introducing the epidural catheter, he realizes that it is torn and for safety he decides to remove it, since it is inserted blindly.Additionally the customer provided the following additional information: the packaging of the material and therefore, as there is no certainty of the integrity of the product.We proceeded to return it to the central pharmacy and not use it on the patient.Another material was used.No damage.

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 9091868.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.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Bd was not able to confirm the customer¿s indicated failure mode.

• Brand Name: BD ANESTHESIA KIT DURASAFE¿
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 9908180
• MDR Text Key: 195313775
• Report Number: 9610847-2020-00119
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 400713
• Device Lot Number: 9091868
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2019
• 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): Other
• Patient Age: 33 YR
• Patient Weight: 91