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

Catalog Number	20059E
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2023
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 smartsite extension set was defective.The following information was received by the initial reporter with the verbatim: we continue to have trouble with the 20059e iv extension sets bursting.This is a problem that popped up about 6 months ago and is now being documented by the ct staff.I have several extensions that we can show you.This was never a problem in the past.While trying to inject contrast using a power injector and the tubing was not able to handle the pressure and popped open x 3.We replaced the tubing 3 times in the patients iv.Each time we injected the tube pressured up and popped open.We are running these sets at 250 psi.
Additional Manufacturer Narrative
Pr# 9006024 tubing defective/ damaged is not reportable as it was found to be user error - this issue is solely the result of user error with no other.Device performance issue, and there has been no device.Related death or serious injury.
Event or Problem Description
No additional information.Material #: 20059e, batch #: unknown.It was reported by customer that they continue to have trouble with the 20059e iv extension sets bursting.This is a problem that popped up about 6 months ago and is now being documented by the ct staff.He/she have several extensions that they can show you.This was never a problem in the past.While trying to inject contrast using a power injector and the tubing was not able to handle the pressure and popped open x 3.They replaced the tubing 3 times in the patients iv.Each time we injected the tube pressured up and popped open.They are running these sets at 250 psi.Verbatim: we continue to have trouble with the 20059e iv extension sets bursting.This is a problem that popped up about 6 months ago and is now being documented by the ct staff.I have several extensions that we can show you.This was never a problem in the past.While trying to inject contrast using a power injector and the tubing was not able to handle the pressure and popped open x 3.We replaced the tubing 3 times in the patients iv.Each time we injected the tube pressured up and popped open.We are running these sets at 250 psi.

• Brand Name: BD ALARIS SMARTSITE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17909838
• Report Number: 9616066-2023-02033
• Device Sequence Number: 12418814
• Product Code: FPA
• UDI-Device Identifier: 37613203012325
• UDI-Public: (01)37613203012325
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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: 20059E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 02/15/2024
• 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