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

Catalog Number 515111

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Event Description

It was reported that foreign matter was found in the expansion chamber of the bd phaseal¿ protector p50j.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about fm in the expansion chamber of protector.The customer reported as follows: to prepare the anticancer agent bevacizumab, the hcp attached p50j.After preparation, the hcp found fm in the expansion chamber.".

Manufacturer Narrative

Medical 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.

Event Description

It was reported that foreign matter was found in the expansion chamber of the bd phaseal¿ protector p50j.The following information was provided by the initial reporter, translated from japanese: "this is a report about fm in the expansion chamber of protector.The customer reported as follows: to prepare the anticancer agent bevacizumab, the hcp attached p50j.After preparation, the hcp found fm in the expansion chamber.".

Manufacturer Narrative

H.6.Investigation summary: one photo was provided to our quality team for investigation.Through visual inspection, dirt was observed inside the expansion chamber.Manufacturing for this product is performed in a clean room, all individuals are required to follow proper gowning procedures before entering the room.We perform inspections and clearly defined cleaning procedures after production of each lot.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.As the lot involved in this incident is unknown, a device history review could not be performed.While we could not identify a direct issue, it was determined the dirt was likely a result of burnt material in the film sealing station.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14246077
• MDR Text Key: 290545820
• Report Number: 3003152976-2022-00177
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1