MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515105

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 with the use of the bd phaseal¿ protector p50 there was an issue with foreign matter inside the chamber.

Event Description

It was reported with the use of the bd phaseal¿ protector p50 there was an issue with foreign matter inside the chamber.

Manufacturer Narrative

H.6.Investigation summary: one picture sample was received for evaluation by our quality engineer.Upon visual inspection of the picture, foreign matter was observed within the expansion chamber.A device history record review was performed for the provided lot number (1712118) and the review did not reveal any quality issues during the production process that could have contributed to this incident.Phaseal products are manufactured within a designated clean area in which all area personnel must follow strict procedures upon entrance.Based on the investigation results, it is not possible to identify the type of foreign matter or the exact cause for this incident.A quality project was opened to improve the cleaning process of the manufacturing lines.The project included updated cleaning frequencies and retraining of the responsible personnel.Lot number 1712118 was produced prior to the implementation of these improvements.It is no possible to confirm the nature of the fm with the picture.No non-conformances were found during dhr review.It is no possible to established the root cause of the defect.To improve the cleaning of the lines, a project was open on fy¿18 (#(b)(4)).The project included new cleaning frequencies and re-training of the personnel in the area.The lot was manufactured before the improvements of the project.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• 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: 8134482
• MDR Text Key: 129601592
• Report Number: 3003152976-2018-00516
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• 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: 01/10/2019

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 Expiration Date: 11/30/2022
• Device Catalogue Number: 515105
• Device Lot Number: 1712118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 11/20/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other