MAUDE Adverse Event Report: BECTON DICKINSON AS LVP SS BAG 20D LOW SORB SS TEX 0.2M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	24301-0007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # (b)(4), batch # unknown.It was reported by customer that the leaking where the texium is bonded to the pump set and set came apart at the connection to the drip chamber.Verbatim: rcc received a complaint via email.Email(s) attached.Reported 2 additional quality issues experienced with 24301-0007t: 1) leaking where the texium is bonded to the pump set.Event occurred on (b)(6) 2024.Lot # is unknown.Set was not saved.2) set came apart at the connection to the drip chamber.Event occurred on (b)(6) 2024.Lot # is unknown.Set was saved.Please provide a shipping label to xxx that is copied on this email.The customer contact is xxx please copy me, xxx and xxx on the communication to the customer that includes the pr #¿s.Customer response on (b)(6) 2024.1.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.2.Could you please confirm if the leak occurred when the set came apart at the connection to the drip chamber? yes.3.Could you please confirm what medication was being administered and leaked.Was this a chemotherapy drug? yes, this was a chemotherapy drug.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual examination was conducted and no damages or abnormalities were identified.The infusion set was then primed and leakage was identified at the distal male luer connector to the texium connector.Further examination of the connection shows that the texium was not correctly threaded on the male luer connector allowing for fluid to leak at the union location.The customer complaint of leakage was initially confirmed.The sample was then forwarded to the manufacturing location for further investigation.After investigation, the exact root cause of leak between texium and male luer could not be determined since the failure mode could not be confirmed / replicated in the sample returned by customer.Although, based on the scenarios performed to try to replicate the failure mode, the possible causes of leak between male luer and texium could be related to incorrect loctite application and incomplete torque between components by the assembler due to no follow up to standard work instructions.No additional actions for the process and equipment were determined for this complaint since the failure mode could not be confirmed / replicated in the sample returned by customer, and the manufacturing site has validated controls and process to prevent this type of failure.Although, no additional actions were needed, a quality alert was created on november 26th, 2024 to communicate the complaint and reinforce the correct production process.A device history record review for model 24301-0007t lot number 24085241 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: AS LVP SS BAG 20D LOW SORB SS TEX 0.2M
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20879388
• Report Number: 9616066-2024-01947
• Device Sequence Number: 15407202
• Product Code: FPA
• UDI-Device Identifier: 10885403223198
• UDI-Public: (01)10885403223198
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: Health Professional
• Device Catalogue Number: 24301-0007T
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown