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

Device Problem Material Separation (1562)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/05/2022

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 304203569
• Report Number: 9616066-2022-01793
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236006
• UDI-Public: (01)10885403236006
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1