MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SYR PSD ASV 20D; INTRAVASCULAR ADMINISTRATION SET

Model Number 10798703

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/29/2022

Event Type  malfunction  

Manufacturer Narrative

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¿ syr psd asv 20d experienced disconnection.The following information was provided by the initial reporter: the micro bore tubing of an alaris bag to syringe iv set became detached from the inline pressure sensing disk.The medication running through the line at the time was hydromorphone, a high alert, opioid that was being administered to manage a patients pain crisis.It is not known how long the line was detached when it was found by the nurse going in to assess the patient at the beginning of their shift.There was no clear indication that the line had become caught or snagged on anything.No immediate issues were noted by nursing staff or the patient.The patient did not report any increased pain and nursing was able to initiate a new set up and hydromorphone bag quickly.Level of harm: no apparent harm - reached patient/person, inconvenient.

Event Description

It was reported that the bd alaris¿ syr psd asv 20d experienced disconnection.The following information was provided by the initial reporter: the micro bore tubing of an alaris bag to syringe iv set became detached from the inline pressure sensing disk.The medication running through the line at the time was hydromorphone, a high alert, opioid that was being administered to manage a patients pain crisis.It is not known how long the line was detached when it was found by the nurse going in to assess the patient at the beginning of their shift.There was no clear indication that the line had become caught or snagged on anything.No immediate issues were noted by nursing staff or the patient.The patient did not report any increased pain and nursing was able to initiate a new set up and hydromorphone bag quickly.Level of harm: no apparent harm - reached patient/person, inconvenient.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-jan-2023.H6: investigation summary one sample was received and tested by our quality team.The separation described by customer at tubing to pressure disc was immediately noticed and the complaint was verified.The tubing was visually analyzed under microscope and there appeared to be no solvent present.The manufacturer was notified of this and the root cause was determined to be improper use of assembly equipment leading to no solvent applied before tubing and disc were joined.A device history record review for model 10798703 lot number 21125233 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.H3 other text : see h10.

• Brand Name: BD ALARIS¿ SYR PSD ASV 20D
• 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: 16080925
• MDR Text Key: 306838120
• Report Number: 9616066-2022-02100
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K811885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/12/2024
• Device Model Number: 10798703
• Device Catalogue Number: 10798703
• Device Lot Number: 21125233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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