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
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem 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.¿.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of hairline crack could not be verified due to the product not being returned for failure investigation.Device history record review for model 11426965 lot number 24015142 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• Common Device Name: 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
• Report Number: 9616066-2024-00488
• Device Sequence Number: 8464643
• Product Code: FPA
• UDI-Device Identifier: 10885403232558
• UDI-Public: (01)10885403232558
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/31/2024

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 Catalogue Number: 11426965
• Device Lot Number: 24015142
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown