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

Catalog Number	11426964
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
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 low sorbing infusion set was damaged the following information was received by the initial reporter with the following: lot # for tubing is (10) 23095809 expiration date of 2026-09-15.On the bd alaris pump infusion set low sorbing tubing ref (b)(4).Tubing defective from oncology floor.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of bag spike broke could not be verified due to the product not being returned for failure investigation.Device history record review for model 11426964 lot number 23095809 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27sep2023.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.
Event or Problem Description
Additional information: 1.Please provide the date of event.3/5.2.Please describe the event elaborately.Nurse went to puncture an iv bag of ns and the bag spike broke in nurse hand while trying to push through the bag spike.All material discarded.3.Any physical sample available for investigation? you have iv line and bag with ref number 4.Did the event directly, or indirectly involve a patient or user? yes it was in front of a pt and by rn.5.Please confirm the number of occurrences: 1.

• Brand Name: BD ALARIS PUMP MODULE LOW SORBING 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: 18976691
• Report Number: 9616066-2024-00477
• Device Sequence Number: 15022851
• Product Code: FPA
• UDI-Device Identifier: 10885403232367
• UDI-Public: (01)10885403232367
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Expiration Date: 09/15/2026
• Device Catalogue Number: 11426964
• Device Lot Number: 23095809
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown