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 12/09/2021

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 that the bd phaseal¿ protector p50j experienced foreign matter in the fluid path.The following information was provided by the initial reporter: during preparation of etoposide, small pieces of coring were found in the infusion bag.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes, d.9.Returned to manufacturer on: 10-apr-2022.H.6.Investigation: infusion bag and c180j connector were received for investigation.Upon visual inspection, no defect was found in the membrane, nor in the spike needle of the connector.Foreign matter particles were observed inside the infusion bag.Fourier transform infrared spectroscopy was performed to identify the foreign matter.The foreign substance was composed of butyl rubber and silicic acid compounds, usually coming from the rubber stopper of the syringe and also from the phaseal membrane (talcum powder).A device history review was performed for reported lot 2104204 , 2105004 2104110 , no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs, or if an incorrect stopper is used as in this case.The product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification that all critical dimensions are within specification and that there is no damage to the product.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.This foreign matter could be determined by the type of quality of this stopper, quality of the cannulas or incorrect use.It is important to ensure that the vial is not expired, as this may affect the quality of the rubber stopper.

Event Description

It was reported that the bd phaseal¿ protector p50j experienced foreign matter in the fluid path.The following information was provided by the initial reporter: during preparation of etoposide, small pieces of coring were found in the infusion bag.

• 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: 13194533
• MDR Text Key: 285480030
• Report Number: 3003152976-2021-00889
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515111
• Device Lot Number: 2104110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2021
• 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
• Treatment: MATL# 515008 LOT# 2105004 INJECTOR LUER LOCK N35J; MATL# 515322 LOT# 2104204 SPIKE CONNECTOR C180J