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

Catalog Number	C25006
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris extension set was occluded.The following was recieved byt the initital reporter: verbatim: customer reported that this alaris microbore tubing is unable to be flushed and upon examination, it's noted that the hub is nearly 100% occluded with plastic, preventing any fluid from being administered.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample (model #c25006, lot #23049331) was returned by the customer.It was reported that alaris microbore tubing is unable to be flushed and upon examination, it was noted that the hub is nearly 100% occluded with plastic, preventing any fluid from being administered.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was connected to a 10ml bd syringe, and attempted to be flushed with water.The syringe was able to be inserted to attempt to flush the set, however the set was unable to be flushed.The customer complaint can be verified.The set was further examined under magnification where a occlusion can be observed at the female luer.A quality notification was sent to the manufacturer.The manufacturer was able to confirm the failure.After further investigation, the possible root cause of occlusion between the tube and female luer is incorrect application of solvent by the assembly.A quality alert was created on october 25th, 2023 to reinforce the correct application of solvent.A device history record review for model c25006 lot number 23049331 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28apr2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see narrative below.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS EXTENSION SET
• Common Device Name: 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: 17435730
• Report Number: 9616066-2023-01593
• Device Sequence Number: 21068416
• Product Code: FPA
• UDI-Device Identifier: 50885403235601
• UDI-Public: (01)50885403235601
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Other
• Device Expiration Date: 04/26/2026
• Device Catalogue Number: C25006
• Device Lot Number: 23049331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown