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

Model Number	72213N
Medical Device Problem Codes	Complete Blockage (1094); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris secondary set experienced tubing kinked and flow issue.The following information was provided by the initial reporter: we had an event last weekend in which a kink in the tubing delayed administration of alteplase for a pe.I would like to log that info in the referral.Also, would it be possible to report this event to the manufacturer? we had a spate of similar events involving secondary iv tubing in (b)(6) of 2022, and i would be curious to know if it was the same product involved.I believe you reported those to the manufacturer.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of tubing kinked - flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the bd alaris secondary set experienced tubing kinked and flow issue.The following information was provided by the initial reporter: we had an event last weekend in which a kink in the tubing delayed administration of alteplase for a pe.I would like to log that info in the referral.Also, would it be possible to report this event to the manufacturer? we had a spate of similar events involving secondary iv tubing in february of 2022, and i would be curious to know if it was the same product involved.I believe you reported those to the manufacturer.

• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16527222
• Report Number: 2243072-2023-00377
• Device Sequence Number: 2661981
• Product Code: FPA
• UDI-Device Identifier: 07613203010078
• UDI-Public: (01)07613203010078
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 03/16/2023

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: 72213N
• Device Catalogue Number: 72213N
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/12/2023
• Supplement Report FDA Received Date: 03/27/2023
• 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