MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D LOW SORB SS 1.2M; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10010453
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
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 the bd alaris¿ lvp 20d low sorb ss 1.2m had a tiny hole in the tubing.The following information was provided by the initial reporter: account states tiny hole in #10010453 tubing.
Event or Problem Description
It was reported that the bd alaris¿ lvp 20d low sorb ss 1.2m had a tiny hole in the tubing.The following information was provided by the initial reporter: account states tiny hole in #10010453 tubing.
Additional Manufacturer Narrative
H6: investigation summary: a complaint of a tiny hole found in the tubing was received from the customer.A sample was received for investigation.Through visual inspection, no damages or defects were noted on the set.The set was primed and infused, and no leakage was observed on the set.The set was then inspected under a microscope and no damage was seen on the set.The defect could not be confirmed.A device history record review for model 10010453 lot number 22125445 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause could not be determined due to the defect not being able to be replicated.This incident has been added to our database of reported incidents.H3 other text : see h10.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB SS 1.2M
• 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: 17283419
• Report Number: 9616066-2023-01382
• Device Sequence Number: 6233550
• Product Code: FPA
• UDI-Device Identifier: 07613203021135
• UDI-Public: 07613203021135
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 07/26/2023

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: 12/15/2025
• Device Catalogue Number: 10010453
• Device Lot Number: 22125445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2022
• 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