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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris secondary set had under infused the following information was received by the initial reporter with the following.It was reported by the customer that they don't drip as fast as they state they do.Usually takes 30 minutes, but this one took over three hours.Used 6 times and still was slow.Ordered 3 cs and used the first 6 and they are all bad.And they don't want to continue using them.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported that the sets were not dripping as fast as they should.100 unopened samples were returned for investigation.The event samples were not returned.Evaluation of 59 samples were performed.The sample size quantity was determined per the sample size selection work instruction.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with water and flow was normal.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 was performed.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
Material: ms3500-15 batch#: 24069124 it was reported by the customer that they don't drip as fast as they state they do.Usually takes 30 minutes, but this one took over three hours.Used 6 times and still was slow.Ordered 3 cs and used the first 6 and they are all bad.And they don't want to continue using them.Verbatim: rcc received a complaint via email.Email(s) attached.Customer called and stated when they opened it up and using them, they don't drip as fast as they state they do.Usually takes 30 minutes, but this one took over three hours.Used 6 times and still was slow.Ordered 3 cs and used the first 6 and they are all bad.And they don't want to continue using them.Item: ms3500-15 quantity affected: 3 cs serial/lot number: n/a po : (b)(6).

• 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: 21160378
• Report Number: 9616066-2024-02267
• Device Sequence Number: 7573336
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/05/2025

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: Other
• Device Catalogue Number: MS3500-15
• Device Lot Number: 24069124
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown