MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MS3500-15
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the tubing separated from the drip chamber.Five unused samples model ms3500-15, lot 22079033 was returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.All sets all had solvent bonding the tubing and drip chamber and the there was no separation.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model ms3500-15 lot number 22079033 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02jul2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that bd alaris secondary set disconnected the following information was received by the initial reporter with the following: occurrence: 2 issue: tubing disconnected from drip chamber causing chemo spill sample: discarded impacted samples but does have representative samples from lot to return for testing adverse events: exposed to chemo comments on 10/06/2024 1.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? a.This happened once when rn took the chemo out of the bag and another time when they were at the wow doing a double check.B.Unclear if any injury but rns and patient exposed to chemo, long term affects unknown 2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.A.Unclear, but nothing immediate 4.Date of event: a.Once on 5/31 and another on 6/1.

• Brand Name: BD ALARIS SECONDARY 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: 19609850
• Report Number: 9616066-2024-00932
• Device Sequence Number: 12352162
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 06/14/2024

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: 07/02/2025
• Device Catalogue Number: MS3500-15
• Device Lot Number: 22079033
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown