MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET.

Catalog Number 10011865

Device Problems Fluid Leak (1250); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd ext set smallbore. 2mf ped, the device experienced leakage. The following information was provided by the initial reporter. The customer stated: it was reported by customer that during a tubing change with inotropes, the tubing appeared to be leaking at the connection of the pall filter and the microbore tubing. During a tubing change with inotropes, the tubing appeared to be leaking at the connection of the pall filter and the microbore tubing. Per the rn it was hard to determine if this issue was at the filter or at the microbore tubing.

• Brand Name: BD EXT SET SMALLBORE .2MF PED
• 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: 13401194
• MDR Text Key: 286924227
• Report Number: 9616066-2022-00042
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790108
• 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: 02/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 10011865
• Device Lot Number: 21079229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial