MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL ¿ INJECTOR LURE LOCK N35J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515008

Device Problem Contamination (1120)

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

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd phaseal ¿ injector lure lock n35j coring led to foreign matter in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: according to the customer¿s report, during preparation of the anticancer agent alimta using p120j and n35j connected to a syringe, coring occurred.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-sep-2022.H6: investigation summary: multiple samples were provided to our quality team for investigation.The product was visually inspected, no defects or damage observed on the protector or injector cannulas or membranes, the protectors fit securely to the vial, the needle on the protector penetrated the vial stopper properly.During our evaluation, a black particle was observed from inside several of the vials.Characterization testing was requested but could not be performed at this time, therefore the composition and origin of the particle could not be determined.A device history review was performed for protector lot 2104123 and injector lot 2105004, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.

Event Description

It was reported while using bd phaseal ¿ injector lure lock n35j coring led to foreign matter in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: according to the customer¿s report, during preparation of the anticancer agent alimta using p120j and n35j connected to a syringe, coring occurred.

• Brand Name: BD PHASEAL ¿ INJECTOR LURE LOCK N35J
• 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: 14363139
• MDR Text Key: 291622511
• Report Number: 3003152976-2022-00207
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 515008
• Device Lot Number: 2105004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: MATERIAL 515113 PROTECTOR SOLUS P120J