MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD CATHETER

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/01/2021

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.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.Medical device expiration date: unknown.The initial reporter also notified the fda on (b)(6) 2021.Medwatch report # (b)(4).Report source other: medwatch report a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ catheter ballooned out.The following information was provided by the initial reporter: it was reported the catheter ballooned out.

Manufacturer Narrative

Correction: this complaint will be cancelled.This is a duplicate complaint of mfr report # 2243072-2021-01358 that has already been reported for malfunction.

Event Description

It was reported that unspecified bd¿ catheter ballooned out.The following information was provided by the initial reporter: it was reported the catheter ballooned out.

• Brand Name: UNSPECIFIED BD CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11953571
• MDR Text Key: 255998571
• Report Number: 2243072-2021-01630
• 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: other
• Type of Report: Initial,Followup
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1