MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P21); INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515102

Device Problem Moisture Damage (1405)

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

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Device expiration date: unknown.Device manufacture date: unknown.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 that a bd phaseal¿ protector (p21) had precipitate, a condition that could lead to leakage.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported that a bd phaseal¿ protector (p21) had precipitate, a condition that could lead to leakage.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.During the manufacturing process, visual inspections and critical tests are performed to ensure that the product is within specification.As there is no lot, retained samples cannot be evaluated and dhr cannot be reviewed.No root cause has been established based on the information provided.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PHASEAL¿ PROTECTOR (P21)
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7926937
• MDR Text Key: 122624890
• Report Number: 3003152976-2018-00419
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

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: 515102
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other