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

Model Number	30914
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd alaris¿ extension set leaked from the tubing during use.The following information was provided by the initial reporter: "rn hung medication, returned to check if it was finished and noticed the tubing was wet, floor had puddle and it seemed like the tubing itself was leaking.Minor effect to patient.".
Event or Problem Description
It was reported that the bd alaris¿ extension set leaked from the tubing during use.The following information was provided by the initial reporter: "rn hung medication, returned to check if it was finished and noticed the tubing was wet, floor had puddle and it seemed like the tubing itself was leaking.Minor effect to patient.".
Additional Manufacturer Narrative
Investigation summary a 30914 extension tubing, a non bd connector and a 50ml bd syringe were received and tested by our quality team.When saline solution was injected into the system via syringe, a leak was noticed between the non bd connector and the extension tubing.This leakage verified the customer's complaint.When the non bd connector was removed however, there was no leakage realized and it is unlikely that there is any issue with the extension tubing.Multiple other connectors were used with the tubing and none leaked.This is evidence that there is not an issue with the set reported in this complaint.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD ALARIS¿ EXTENSION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14162127
• Report Number: 9616066-2022-00443
• Device Sequence Number: 5932352
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 08/10/2022

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: Health Professional
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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