MAUDE Adverse Event Report: BECTON DICKINSON IV SET/60DROP/WR3CQ/RE/STD/100CM; INTERVASCULAR ADMINISTRATION SET

Catalog Number 385565-ZAT

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

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.Oem manufacture: 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.

Event Description

It was reported that the iv set/60drop/wr3cq/re/std/100cm experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: lot reverse order occurred.

Manufacturer Narrative

H.6.The complaint has been clarified that there was no labeling error, therefore it is not a reportable event, and the mdr should be considered cancelled.H3 other text : see h.10.

Event Description

It was reported that the iv set/60drop/wr3cq/re/std/100cm experienced incorrect label information which was noted prior to use.The following information was provided by the initial reporter: lot reverse order occurred.

• Brand Name: IV SET/60DROP/WR3CQ/RE/STD/100CM
• Type of Device: INTERVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9856657
• MDR Text Key: 186283832
• Report Number: 2243072-2020-00447
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385565-ZAT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 06/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other