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	Material Separation (1562)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material#: 24301-0007t, 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.Rcc received a complaint via email.Xxxx reported 2 additional quality issues experienced with 24301-0007t: 1) leaking where the texium is bonded to the pump set.Event occurred on 11/21/2024.Lot# is unknown.Set was not saved.2) set came apart at the connection to the drip chamber.Event occurred on 11/21/2024.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
One sample was received for quality evaluation.Visual inspection was conducted on the samples and the drip chamber was missing its top.Further examination of the drip chamber does not indicate any bonding solvent at the top of the drip chamber.The customer complaint of separation other component - leak was confirmed.The investigation was forwarded to the manufacturer of the drip chamber.After the investigation, it was determined that the failure was due to a low quantity of solvent dispensed in the gluing area between the drip chamber body and drip chamber upper assembly.The lot of the component was investigated for similar issues but there were no other issues similar to this issue reported for a lot of (b)(4) parts, and therefore a root cause could not be fully determined.A probable root cause of the lack of glue maybe related to the startup phase of the assembly process and the equipment did not dispense the correct amount of glue at startup, however, this hypothesis could not be verified.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: 20879358
• Report Number: 9616066-2024-01948
• Device Sequence Number: 15374458
• 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