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

Catalog Number	MY8010
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.The initial reporter also notified the fda.Medwatch report # (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd texium¿ needle-free syringe was blocked when attached to the spinal needle.Three attempts were made to inject without success.The following information was provided by the initial reporter: "patient was sedated for lumbar puncture with intrathecal chemotherapy.Lumbar puncture and csf collection completed without problem, attempted to attach it chemo syringe to hub of spinal needle, some flash of yellow methotrexate fluid noted, but once fully attached, could not infuse chemo, plunger would not budge.Removed, readjusted, and re-attached, still would not infuse.Removed again, spinal needle inspected by attending and csf noted to still be freely flowing.Third attempt also unsuccessful.".
Event or Problem Description
It was reported that the bd texium¿ needle-free syringe was blocked when attached to the spinal needle.Three attempts were made to inject without success.The following information was provided by the initial reporter: "patient was sedated for lumbar puncture with intrathecal chemotherapy.Lumbar puncture and csf collection completed without problem, attempted to attach it chemo syringe to hub of spinal needle, some flash of yellow methotrexate fluid noted, but once fully attached, could not infuse chemo, plunger would not budge.Removed, readjusted, and re-attached, still would not infuse.Removed again, spinal needle inspected by attending and csf noted to still be freely flowing.Third attempt also unsuccessful.".
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint that the set would not infuse could not be verified due to the product not being returned for failure investigation.A device history record review for model my8010 lot number 92127202 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: BD TEXIUM¿ NEEDLE-FREE SYRINGE
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16251613
• Report Number: 9616066-2023-00098
• Device Sequence Number: 5351688
• Product Code: FMF
• UDI-Device Identifier: 10885403221675
• UDI-Public: 10885403221675
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K071108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/29/2024
• Device Catalogue Number: MY8010
• Device Lot Number: 92127202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 28 KG