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	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris secondary set leaking.The following information was provided by the initial reporter with the verbatim: customer concerned that where the locking injector and secondary set (ms3500-15) connect, there are droplets present.Concerned it could be leaking.Walked them through proper injector connection technique.
Event or Problem Description
No additional information was provided.Mat#: ms3500-15, batch#: 23069240.It was reported by customer that where the locking injector and secondary set (ms3500-15) connect, there are droplets present.Concerned it could be leaking.Verbatim: customer concerned that where the locking injector and secondary set (ms3500-15) connect, there are droplets present.Concerned it could be leaking.Walked them through proper injector connection technique.(b)(6) 2023 here are the lot numbers of the current products that we have.There was no patient involvement in this instance.Phaseal optima injector (n40-o), ref: 515056, lot:2305308, man date:2023-05-01, exp:2025-10-31.Bd secondary set, ref: ms3500-15, alaris products, exp: 2026-06-16, lot: (10) 23069240, (01)10885403222610.This complaint is based on an observation when preparing chemo.The secondary set is primed in an open fashion with plain fluid, then the injector is attached to the line.Once connected, if you tap the injector on the counter, droplets will release at the connection site.Where would the droplets come from?.
Additional Manufacturer Narrative
It was reported by customer that they were using a secondary set, ms3500-15, and concerned it could be leaking.No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model ms3500-15 lot number 23069240 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 18080941
• Report Number: 9616066-2023-02147
• Device Sequence Number: 7823425
• Product Code: FPA
• UDI-Device Identifier: 50885403222618
• UDI-Public: (01)50885403222618
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: MS3500-15
• Device Lot Number: 23069240
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown