MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10014918

Device Problem Complete Blockage (1094)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd alaris syringe module syringe administration set was damaged the following information was received by the initial reporter with the following verbatim: reading "occluded" even when detached from the patient.Med line tubing was disconnected from the patient and still read "occluded" on the alaris pump.Because of this, about 0.2ml of medication was unable to be given to patient.No harm to patient.

Event Description

No additional info.

Manufacturer Narrative

It was reported that the line occluded.One sample model 10014918 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with normal saline and no observations of oclussion occurred.The customer complaint was unable to be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review could not be performed because a lot number was not provided by the customer.

• Brand Name: BD ALARIS SYRINGE MODULE SYRINGE ADMINISTRATION SET
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18635363
• MDR Text Key: 334652199
• Report Number: 9616066-2024-00163
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403233944
• UDI-Public: (01)10885403233944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10014918
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1