MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 11426965

Device Problem Leak/Splash (1354)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim good afternoon.On 2/29/2024, we had a safety event reported for bd item # 11426965 (bd alaris pump tubing).Let¿s identify this as bd 265, as a reference number.The defective product has been discarded by the clinicians.Based on the information provided below, could you start a product quality report? event details: ¿prior to starting docetaxel - noted left side of bed was saturated with clear liquid including patient left sleeve clothing.Iv site left antecubital - dry and intact, good blood return.Iv tubing assessed and found a leak from end of tubing connection and luer lock.Upon further investigation a hairline crack was seen screw side of tubing.Patient verbalized she didn't feel sleepy after benadryl was given.Iv set up changed entirely.Aprn was notified - and was instructed to re-dose with all pre medications - dexamethasone, benadryl, pepcid and zofran.¿.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19001791
• MDR Text Key: 338931110
• Report Number: 9616066-2024-00488
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232558
• UDI-Public: (01)10885403232558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11426965
• Device Lot Number: 24015142
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1