MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; ADMINSTRATION SET

Catalog Number 515111

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during use of the bd phaseal¿ protector p50j there was an issue with preparing the medication with the device.It was stated ¿at the time of preparation, the chemical liquid flowed into the expansion bladder.User pulled the syringe in order to return the chemical solution in the expansion bladder to the vial but could not move from the expansion bladder.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

The initial mdr was a duplicate of mfr report #: 3003152976-2018-00133 and is therefore over-reported.(b)(4).Is being cancelled as it was opened in error and is a duplicate of (b)(4).

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: ADMINSTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7443282
• MDR Text Key: 106247946
• Report Number: 3003152976-2018-00154
• Device Sequence Number: 1
• Product Code: LHI
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 515111
• Device Lot Number: 1703107
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other