MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MICROBORE EXTENSION SET, IV CONNECTOR, T; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZXT9001
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 92 of the microbore extension set, iv connector, t experienced print permanency.The following information was provided by the initial reporter: the 92 ca of almzxt9001 were mixed in multiple lots, because the lot # and expiry date printed on the product are too small and too light to be identified.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary: one photo of the product packaging was received for quality investigation.The customer complaint of package pring permanency could not be verified by evaluation of the photo provided.The photo provided shows the box for the product.Although the photo is blurry, it does not look as if the lot number or expiration date is missing from the packaging.Based on the photo provided, it cannot be determined if the lot number and expiration date is too blurry to be legible.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 92 of the microbore extension set, iv connector, t experienced print permanency.The following information was provided by the initial reporter: the 92 ca of almzxt9001 were mixed in multiple lots, because the lot # and expiry date printed on the product are too small and too light to be identified.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR, T
• 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: 17192191
• Report Number: 9616066-2023-01240
• Device Sequence Number: 12615890
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: 10885403240805
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140831
• 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): 07/14/2023

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 Catalogue Number: MZXT9001
• 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: 05/31/2023
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/03/2023
• 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