MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NEXIVA¿ CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

It was reported that the unspecified bd nexiva¿ catheter tip was found damaged before performing the venipuncture.The following information was provided by the initial reporter, translated from (b)(6): "on (b)(6) 2021, when the nurse on duty was preparing for venipacture for the child, she checked the puncture needle and found that the catheter tube was damaged.She immediately released the tourniquet, replaced the indwelling needle, disinfected it again, and re-punctured it.".

Manufacturer Narrative

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.The reported lot# 0267148 was provided, but all corresponding material numbers did not match the product described in the event.Medical 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.

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no item number, sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint could not be confirmed and the root cause is undetermined.

Event Description

It was reported that the unspecified bd nexiva¿ catheter tip was found damaged before performing the venipuncture.The following information was provided by the initial reporter, translated from chinese: "on 2021-09-13, when the nurse on duty was preparing for venipacture for the child, she checked the puncture needle and found that the catheter tube was damaged.She immediately released the tourniquet, replaced the indwelling needle, disinfected it again, and re-punctured it".

• Brand Name: UNSPECIFIED BD NEXIVA¿ CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13500140
• MDR Text Key: 286587698
• Report Number: 2243072-2022-00173
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 05/09/2022
• Supplement Dates FDA Received: 05/12/2022
• 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