MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA SYRINGE

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 3 anesthesia 17 ga x 18 cm durasafe experienced a needle hub hole/cracked/damaged.Product defect was noted during use.The following information was provided by the initial reporter: in the process of using the product, the cannel and the connector (yellow position) fell off.

Manufacturer Narrative

Investigation summary unfortunately a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.Preventing our investigation team from conducting a device history review.Additionally the device in the provided photograph is not a bd product.Additionally the device in the photograph was a female luer connector making it incompatible with the bd epidural catheter identified in the complaint.At this time we are not able to determine a root cause for this event.If a photograph of a bd product or a device returned this complaint will be reopened.Bd will continue to track and trend for this issue.

Event Description

It was reported that 3 anesthesia 17gax18cm durasafe experienced a needle hub hole/cracked/damaged.Product defect was noted during use.The following information was provided by the initial reporter: in the process of using the product, the cannel and the connector (yellow position) fell off.

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: ANESTHESIA SYRINGE
• MDR Report Key: 10129396
• MDR Text Key: 204747811
• Report Number: 3006948883-2020-00218
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other