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

Catalog Number	MZT1003
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd extension set pressure rated minibore the tubing was clogged.There was no report of patient impact.The following information was provided by the initial reporter: 1980-pc: microbore extension tubing is occluded right from the package.  the product is useless in this form.
Event or Problem Description
It was reported while using bd extension set pressure rated minibore the tubing was clogged.There was no report of patient impact.The following information was provided by the initial reporter: 1980-pc: microbore extension tubing is occluded right from the package.  the product is useless in this form.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint that the set was unable to flush could not be verified due to the product not being returned for failure investigation.A device history record review for model mzt1003 lot number 21065408 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.

• Brand Name: BD EXTENSION SET PRESSURE RATED MINIBORE
• 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 ; 8448235433
• MDR Report Key: 16950977
• Report Number: 9616066-2023-00935
• Device Sequence Number: 3614161
• Product Code: FPA
• UDI-Device Identifier: 10885403471247
• UDI-Public: (01)10885403471247
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2023

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 Expiration Date: 06/11/2024
• Device Catalogue Number: MZT1003
• Device Lot Number: 21065408
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 06/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2021
• 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