MAUDE Adverse Event Report: BECTON DICKINSON IV-SET P 180 CM PVC RLS L-L; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 396353

Device Problem Failure to Infuse (2340)

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

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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 # [1010728] was not found for the reported catalog # [396353].Medical device expiration date: unknown.(b)(6).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 the iv-set p 180 cm pvc rls l-l "cannot be vented" and couldn't infuse the "antibiotics and infusions (e.G.Sterofundin)".

Manufacturer Narrative

Additional information was received from the customer clarifying there was no leakage of medication.This event is no longer reportable.

Event Description

It was reported that the iv-set p 180 cm pvc rls l-l "cannot be vented" and couldn't infuse the "antibiotics and infusions (e.G.Sterofundin)".

• Brand Name: IV-SET P 180 CM PVC RLS L-L
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8356272
• MDR Text Key: 139096120
• Report Number: 2243072-2019-00296
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 396353
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other