MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD TEXIUM¿ NEEDLE-FREE SYRINGE; PISTON SYRINGE

Catalog Number MY8030-0006

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 07/19/2023

Event Type  malfunction  

Event Description

It was reported that a disconnection occurred between the bd texium¿ needle-free syringe and texium connector, causing chemotherapy medication to leak into the isolator's working chamber.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from italian: "disconnection between texium connector and syringe resulting in drug spillage in the weeks from (b)(6) 2023 to (b)(6) 2023.Five incidents occurred with texium syringes code my8030-0006 from the company becton dickinson batch no.92220701 with expiry date 26.07.2025.Specifically, when the chemotherapy drug was withdrawn from the bottle, a disconnection occurred between the texium connector and the syringe with consequent spillage of chemotherapy drug (irinotecan and 5-fu).It should be noted that these incidents occurred within the isolator's working chamber, thus avoiding contamination of the operator and patient".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 27-sep-2023.H.6.Investigation summary: two hundred and fifty samples from lot 92220701 were received in sealed packaging for investigation.The feedback provided by the customer suggests a separation of the texium was observed from the syringe resulting in leakage.A visual inspection of the returned samples did not identify any obvious damage or manufacturing defects which could have caused or contributed to the customer's experience.Twenty-five samples were then subjected to functional testing by manually applying force at the texium connection; no separation was detected throughout testing.The samples were then connected to a bd maxzero device from stock; again a secure connection was detected and no flow issues were detected throughout testing.The samples were then subjected to pressure testing; no leakage was detected at the texium connection throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.The alleged complaint sample was not available for investigation therefore it was not possible to confirm whether a manufacturing defect may have contributed to the customer's experience.A review of the production records for lot 92220701 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the my8030-0006 product over the past 12 months.H3 other text : see h10.

Event Description

It was reported that a disconnection occurred between the bd texium¿ needle-free syringe and texium connector, causing chemotherapy medication to leak into the isolator's working chamber.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from italian: "disconnection between texium connector and syringe resulting in drug spillage in the weeks from 03.07.2023 to 18.07.2023.Five incidents occurred with texium syringes code my8030-0006 from the company becton dickinson batch no.92220701 with expiry date 26.07.2025.Specifically, when the chemotherapy drug was withdrawn from the bottle, a disconnection occurred between the texium connector and the syringe with consequent spillage of chemotherapy drug (irinotecan and 5-fu).It should be noted that these incidents occurred within the isolator's working chamber, thus avoiding contamination of the operator and patient".

• Brand Name: BD TEXIUM¿ NEEDLE-FREE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17477456
• MDR Text Key: 320873525
• Report Number: 9616066-2023-01670
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MY8030-0006
• Device Lot Number: 92220701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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