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

Catalog Number 10013364T

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported that 9 of the bd alaris medical infusion system administration sets were kinked.The following was recieved by the initial reporter: verbatim : i have another set of these items that are kinked to the point of not being usable.Please advise if you would like me to ship them or toss them.I believe the first set listed below is one that we have already submitted.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot #: 22119295, d4.Medical device expiration date: 11nov2025, h4.Device manufacture date: 16nov2022.D4.Medical device lot #: 23019326, d4.Medical device expiration date: 24jan2026, h4.Device manufacture date: 21jan2023.D4.Medical device lot #: 23019280 d4.Medical device expiration date: 24j,an2026, h4.Device manufacture date: 17jan2023.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 9 of the bd alaris medical infusion system administration sets were kinked.The following was received by the initial reporter: verbatim : i have another set of these items that are kinked to the point of not being usable.Please advise if you would like me to ship them or toss them.I believe the first set listed below is one that we have already submitted.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-jul-2023.H6: investigation summary a complaint of tubing being kinked was received from the customer.A sample of lot 23019280 was received for investigation.Through visual inspection, the customer complaint was confirmed.The tubing below the drip chamber was kinked inside the packaging.A device history record review for model 10013364t lot number 23019280 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 a review of the manufacturing process was completed.After review, the potential root cause of kinked tubing could be related to an improper coiling of the product by the assembler due to incorrect following of the sws and the procedure.

• 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: 17410818
• MDR Text Key: 320224684
• Report Number: 9616066-2023-01560
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403198913
• UDI-Public: (01)50885403198913
• Combination Product (y/n): Y
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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: 10013364T
• Device Lot Number: 22119295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 07/27/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• 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