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

Catalog Number 515111

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 12/11/2018

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 that "hair like" foreign matter was found in the bd phaseal¿ protector p50j.

Manufacturer Narrative

H.6.Investigation summary: one sample unit was received for evaluation by our quality engineer team.Through visual inspection of the sample, a piece of hair was found within the expansion chamber.A device history record review was performed for the provided lot number (1804125) and the review did not reveal any quality issues during the production process that could have contributed to this incident.Phaseal products are manufacturing and assembled in a designated clean area.Personnel are required to follow strict gowning and preventive procedures prior to entering the clean area.To improve the cleaning of the lines, a project was open on fy¿18 (#1436).The project included new cleaning frequencies and re-training of the personnel in the area.The project has decreased the number of complaints related to fm.The lot was manufactured when the improvements were being launched.Personnel of the area has been aware of the complaint.

Event Description

It was reported that "hair like" foreign matter was found in the bd phaseal¿ protector p50j.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8206070
• MDR Text Key: 131723463
• Report Number: 3003152976-2018-00569
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 515111
• Device Lot Number: 1804125
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other