MAUDE Adverse Event Report: BECTON DICKINSON BD¿ VENTED IV SET; INTRAVASCULAR CATHETER

Catalog Number 388000

Device Problems Leak/Splash (1354); Scratched Material (3020)

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

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.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.Date of event: unknown.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 leakage occurred from a crack in the chamber of the bd¿ vented iv set.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Correction: the initial mdr 595877, mfr.Report # 2243072-2018-01408, indicated an investigation would be reported.This complaint was opened in error and was re-opened in the correct complaint management system, reference (b)(4).No additional information or investigation will be presented here.

Event Description

It was reported that leakage occurred from a crack in the chamber of the bd vented iv set.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD¿ VENTED IV SET
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7925948
• MDR Text Key: 122655962
• Report Number: 2243072-2018-01408
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 388000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other