MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD CATHETER

Catalog Number UNKNOWN

Device Problems Crack (1135); Appropriate Term/Code Not Available (3191)

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

Event Date 01/25/2019

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.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that the unknown bd catheter couldn't be punctured into by the nurse, leading to the discovery of a crack on the front of the device.The customer reported, ¿nurse feedback catheter couldn't be punctured into, after pulling out, a crack was found in the front end.Md registration certificate (b)(6)¿.

Manufacturer Narrative

H.6.Investigation summary: a lot number could not be connected to the device identified in the complaint, so bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode.

Event Description

It was reported that the unknown bd catheter couldn't be punctured into by the nurse, leading to the discovery of a crack on the front of the device.The customer reported, ¿nurse feedback catheter couldn't be punctured into, after pulling out, a crack was found in the front end.Md registration certificate#: (b)(4)¿.

• Brand Name: UNKNOWN BD CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8383503
• MDR Text Key: 139209009
• Report Number: 2243072-2019-00355
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other