MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Model Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd alaris¿ pump module administration sets the tubing separated.The following information was provided by the initial reporter: it was reported by customer that the tubing came apart while infusing.
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
D10: device available for eval: no d10: returned to manufacturer on: na.H6: investigation summary: no photo or sample was received with the customer's complaint of separation.Without further evidence like a physical sample, the complaint cannot be verified and the root cause remains unknown.A device history record review could not be performed because a lot number was not provided by the customer.
Event or Problem Description
It was reported that while using bd alaris¿ pump module administration sets the tubing separated.The following information was provided by the initial reporter: it was reported by customer that the tubing came apart while infusing.

• Brand Name: BD ALARIS¿ PUMP MODULE ADMINISTRATION SETS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13028633
• Report Number: 9616066-2021-52603
• Device Sequence Number: 14609380
• Product Code: FPA
• UDI-Device Identifier: 37613203019690
• UDI-Public: 37613203019690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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 Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown