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

Catalog Number	10010570
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional 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 #: 22069155.D4.Medical device expiration date: 13-jun-2025.H4.Device manufacture date: 06-jun-2022.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris micro extension set air entered the line.There was no report of patient impact.The following information was provided by the initial reporter: so the nurses have found a flaw with the bd extension tubing that is currently being stocked in bin l#94052.It tends to suck in air.The nurses have found a work around by using a blue clave to prevent this.Because no matter how much they pinch the line.Air get in.
Additional Manufacturer Narrative
H6: investigation summary two samples model 10010570, lot 22079028 were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The set was successfully primed with no air bubbles.The customer complaint that the tubing was sucking in air could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 10010570 lot number 22079028 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported while using bd alaris micro extension set air entered the line.There was no report of patient impact.The following information was provided by the initial reporter: so the nurses have found a flaw with the bd extension tubing that is currently being stocked in bin l#94052.It tends to suck in air.The nurses have found a work around by using a blue clave to prevent this.Because no matter how much they pinch the line.Air get in.

• Brand Name: BD ALARIS MICRO 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16802317
• Report Number: 9616066-2023-00756
• Device Sequence Number: 11217844
• Product Code: FPA
• UDI-Device Identifier: 10885403233500
• UDI-Public: (01)10885403233500
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Operator of Device: Other
• Device Expiration Date: 07/05/2025
• Device Catalogue Number: 10010570
• Device Lot Number: 22079028
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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