MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMALL BORE J-LOOP EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	30204E
Medical Device Problem Codes	Backflow (1064); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 small bore j-loop extension set backflow and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the j-loop is leaking from the site where the tubing connects into the end of the tubing.They also stated blood was backing up into the tubing and the j-loop needed to be changed.Verbatim: j-loop is leaking from the site where the tubing connects into the end of the tubing.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation.No product (mat # mz5317) was returned by the customer.Photos representation was provided for the complaint.It was reported by the customer that the j-loop is leaking from the site where the tubing connects into the end of the tubing.They also stated blood was backing up into the tubing and the j-loop needed to be changed.The photos could not verify the complaint.The root cause cannot be determined without the physical sample for investigation.A device history record review could not be performed because a lot number was not provided by the customer.The root cause of this complaint could be unknown as no sample received.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: BD SMALL BORE J-LOOP 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16802283
• Report Number: 9616066-2023-00757
• Device Sequence Number: 20616102
• Product Code: FPA
• UDI-Device Identifier: 50885403235175
• UDI-Public: (01)50885403235175
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2024

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 Model Number: 30204E
• Device Catalogue Number: MZ5317
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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