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

Model Number	30914
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21109145.Medical device expiration date: 2024-10-14.Device manufacture date: 2021-10-14.Medical device lot #: 21079057.Medical device expiration date: 2024-07-15.Device manufacture date: 2021-07-09.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 9 total bd alaris¿ extension sets from various, unspecified lots had flow and blockage issues where they couldn't be primed.The following information was provided by the initial reporter: "we are continuing to have issues with this tubing with different lot numbers.We have had three more incidents that have had tubing that is unable to prime.".
Event or Problem Description
It was reported that 9 total bd alaris¿ extension sets from various, unspecified lots had flow and blockage issues where they couldn't be primed.The following information was provided by the initial reporter: "we are continuing to have issues with this tubing with different lot numbers.We have had three more incidents that have had tubing that is unable to prime.".
Additional Manufacturer Narrative
H.6.Investigation: four samples were returned for investigation by the customer.During the visual inspection of the samples the female luer (part number: 630-01364) an occlusion was observed in two of the four samples.The customer complaint that they are unable to flush through the tubing set was able to be replicated for two of the four samples.A quality notification was sent to the manufacturer.From the manufacturer investigation it is determined in qn that the flow meter tends to stick, making it impossible for the operator to identify occlusions in the process.As a preventive action the maintenance personal cleans the flow meter and used ionized air to reduce the static in the flow meter.As contention action a training was performed to the flow meter digital.A device history report was completed for the possible lots given: a device history record review for model 30914 lot number 21109145 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 30914 lot number 21079057 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13480959
• Report Number: 9616066-2022-00088
• Device Sequence Number: 12109481
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/15/2022

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 Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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