MAUDE Adverse Event Report: BECTON DICKINSON SEC SET NO PORTS W/HANGER DEHP FREE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	11448964
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:11448964.Batch#:23019376.It was reported by customer that the operator set up a secondary infusion, connecting to a primary set that routed through an infusion pump.The primary set was equipped with the required back-check valve for a secondary infusion.The secondary set was spiked into a glass container with the drip chamber vent open.The primary line was spiked into an iv bag with the vent closed.The secondary container was positioned with the fluid level 39 cm higher than the fluid level in the primary container.A 500 ml/hr infusion was started on the infusion pump.Observing the drip chambers it was evident that the majority of flow was coming from the primary container.When the operator inspected the vent on the secondary drip chamber and gently tapped it with a hemostat, the flow switched to coming primarily through the secondary container instead of the primary container.
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 #: 11448964.Batch#: 23019376.It was reported by customer that the operator set up a secondary infusion, connecting to a primary set that routed through an infusion pump.The primary set was equipped with the required back-check valve for a secondary infusion.The secondary set was spiked into a glass container with the drip chamber vent open.The primary line was spiked into an iv bag with the vent closed.The secondary container was positioned with the fluid level 39 cm higher than the fluid level in the primary container.A 500 ml/hr infusion was started on the infusion pump.Observing the drip chambers it was evident that the majority of flow was coming from the primary container.When the operator inspected the vent on the secondary drip chamber and gently tapped it with a hemostat, the flow switched to coming primarily through the secondary container instead of the primary container.Rcc received a complaint via email.Operator set up a secondary infusion, connecting to a primary set that routed through an infusion pump.The primary set was equipped with the required back-check valve for a secondary infusion.The secondary set was spiked into a glass container with the drip chamber vent open.The primary line was spiked into an iv bag with the vent closed.The secondary container was positioned with the fluid level 39 cm higher than the fluid level in the primary container.A 500 ml/hr infusion was started on the infusion pump.Observing the drip chambers it was evident that the majority of flow was coming from the primary container.When the operator inspected the vent on the secondary drip chamber and gently tapped it with a hemostat, the flow switched to coming primarily through the secondary container instead of the primary container.
Additional Manufacturer Narrative
It was reported by customer the flow switched to coming primarily through the secondary container instead of the primary container.One sample was received.Visual examination was conducted on the sample and no damages or abnormalities were identified.The secondary set was then primed with water and attached to a bd primary infusion set and a simulated infusion was conducted at a rate of 125 ml/hr for 1 hour and the volume dispensed was captured in a calibrated graduated cylinder.There were no leakages, air-in-line, occlusions or signs of backflow.The customer complaint of flow issues - accuracy could not be confirmed.A root cause was not determined because the failure was not replicated.A device history record review for model 11448964, lot number 23019376 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: SEC SET NO PORTS W/HANGER DEHP FREE
• 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: 20880418
• Report Number: 9616066-2024-01955
• Device Sequence Number: 12725308
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: (01)10885403234743(11)230130(17)260131(10)23019376
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/13/2025

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 Expiration Date: 01/31/2026
• Device Catalogue Number: 11448964
• Device Lot Number: 23019376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/13/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown