MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10802688

Device Problem Material Deformation (2976)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

H3.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 that the bd alaris medical infusion system administration set had kinked tubing.The following was received by the initial reporter: verbatim: t: fluids will flow freely in iv tubing a: when priming with lr, rn noticed fluids would not flow freely.Upon inspection it was noted the tubing was kinked below the drip chamber.Rn was unable to release the kink in the tubing.Was there any harm or injury to the patient, health care provider, or any other person?: no.

Manufacturer Narrative

H6: investigation summary a photo was provided by the customer where a kink can be seen below the drip chamber.The customer complaint was confirmed.A device history record review for model 10802688 lot number 23059044 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and an investigation was performed.After investigation, the potential root cause of kinked tubing could be related to an incorrect solvent application due to issues with the solvent dispenser and incorrect coiling of the set by the assembler.This defect was addressed with updates to the work instruction to add the correct solvent dispenser to carry out the assembly of tubing to the drip chamber.

Event Description

It was reported that the bd alaris medical infusion system administration set had kinked tubing.The following was received by the initial reporter: verbatim: t: fluids will flow freely in iv tubing.A: when priming with lr, rn noticed fluids would not flow freely.Upon inspection it was noted the tubing was kinked below the drip chamber.Rn was unable to release the kink in the tubing.Was there any harm or injury to the patient, health care provider, or any other person? no.

• Brand Name: BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17400504
• MDR Text Key: 320375362
• Report Number: 9616066-2023-01535
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: 10885403234439
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• 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: 10/11/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 10802688
• Device Lot Number: 23059044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2023
• 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