MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD 12 IN NON-DEHP MINIBORE EXTENSION SET CLOSE; INTRAVASCULAR ADMINISTRATION SET

Model Number	ME1048
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd 12 in non-dehp minibore extension set close fell into 3 pieces.The following information was provided by the initial reporter: rn decided to move vasopressin line closer to the patient in the gtt line but when she went to unscrew the medication tubing it fell into 3 pieces.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 11-nov-2023.H6: investigation summary the customer reported separation into three pieces on material me1048, and returned the affected sample.The sample was clearly separated at the male luer, and no male luer was returned.The tubing had lots of glue residue on the tubing, and the root cause is not known.There are a couple possible root causes, excess solvent applied during assembly, and excessive force by user that removes the luer.Neither of these can be proven in this case, and the root cause is not known.A device history record review could not be performed on material me1048 because the lot number is unknown.
Event or Problem Description
It was reported that the bd 12 in non-dehp minibore extension set close fell into 3 pieces.The following information was provided by the initial reporter: rn decided to move vasopressin line closer to the patient in the gtt line but when she went to unscrew the medication tubing it fell into 3 pieces.

• Brand Name: BD 12 IN NON-DEHP MINIBORE EXTENSION SET CLOSE
• 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 ; 8015296192
• MDR Report Key: 15852739
• Report Number: 9616066-2022-01793
• Device Sequence Number: 12025566
• Product Code: FPA
• UDI-Device Identifier: 10885403236006
• UDI-Public: (01)10885403236006
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 03/07/2023

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 Model Number: ME1048
• Device Catalogue Number: ME1048
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 03/15/2023
• 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