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

Catalog Number UNKNOWN

Device Problem Defective Device (2588)

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

Event Date 07/19/2022

Event Type  malfunction  

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.(b)(4).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.

Event Description

It was reported that during use of the unspecified bd cathena¿ catheter, the catheter material had been blown the following information was provided by the initial reporter: when nurse tried to advance the catheter she noticed she had blown through the vein.She then removed the catheter and needle from the patient to realize the catheter material had been blown as well.My initial guess was that the nurse tried to re-thread the catheter but after speaking with her she said this was not the case.

Event Description

It was reported that during use of the unspecified bd cathena¿ catheter, the catheter material had been blown the following information was provided by the initial reporter: when nurse tried to advance the catheter she noticed she had blown through the vein.She then removed the catheter and needle from the patient to realize the catheter material had been blown as well.My initial guess was that the nurse tried to re-thread the catheter but after speaking with her she said this was not the case.

Manufacturer Narrative

Investigation summary: two photos were received by our quality team for evaluation.From the photos, the team observed the needle pierced through the catheter.A device history record could not be evaluated as the lot number is unknown.As no sample was returned for further investigation, a root cause could not be established.This incident has been added to our database of reported incidents.

• Brand Name: UNSPECIFIED BD CATHENA¿ 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: 15210642
• MDR Text Key: 304888217
• Report Number: 2243072-2022-01318
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• 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