MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP5312-C
Medical Device Problem Codes	Leak/Splash (1354); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxplus¿ pressure rated extension set with needleless connector had a loose connection to the angio catheter, and sprayed out medication onto the patient's back as a result.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "the manifolds have been coming apart and leaking, and the connection with the extention to the angio seems to not screw on very tight and leaks at that spot.Bd max plus pressure rated ext set - # mp5312-c not fully securing to angio cath where circled below causing leakage.Details: pt.Was in endo being put to sleep and the anesthesia provider stated that the connection of item 7592897 to the angio was leaking.He tightened that connection then went to the manifold (7570763), started giving propofol and the connection there came apart completely and sprayed the patient down her back.There was no adverse event.It just delayed the patient getting to sleep for the procedure.Procedure: egd and colonoscopy".
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: a complaint of connection to angio not connecting properly and leaking was received from the customer.A photo of the component with connection issues was provided.The defect cannot be seen in the photo.A device history record review could not be performed on model mp5312-c 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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD MAXPLUS¿ PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 16778545
• Report Number: 9616066-2023-00737
• Device Sequence Number: 17810154
• Product Code: FPA
• UDI-Device Identifier: 10885403230158
• UDI-Public: 10885403230158
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Report Date (Section B): 04/01/2023

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: Health Professional
• Device Catalogue Number: MP5312-C
• 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: 03/28/2023
• Initial Report FDA Received Date: 04/20/2023
• 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