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	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ extension set tubing was blocked and medication couldn't be flushed through.The following information was provided by the initial reporter: "unable to flush medication through syringe tubing".
Additional Manufacturer Narrative
Correction: the lot# was provided by the customer.The following fields have been updated: d.2.Medical device lot#: 21109141.D.4.Medical device expiration date: 12-oct-2024.H.4.Device manufacture date: 11-oct-2021.
Event or Problem Description
It was reported that the bd alaris¿ extension set tubing was blocked and medication couldn't be flushed through.The following information was provided by the initial reporter: "unable to flush medication through syringe tubing".
Event or Problem Description
It was reported that the bd alaris¿ extension set tubing was blocked and medication couldn't be flushed through.The following information was provided by the initial reporter: "unable to flush medication through syringe tubing.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 13-may-2022.H6: investigation summary : one sample model 30914 was received for investigation.The set was examined for defects and abnormalities.Excess solvent was seen at the male luer.The customer complaint that they are unable to flush tubing was verified.A quality notification was sent to the manufacturer.The root cause was found to be that the air sweep time was not enough and the lack of rest time.It is necessary to ensure that the first piece in is the first piece out, to have the longest resting time in the manufacturing process.All operators will be informed through a quality alert as a preventative action in the next production model plan.The frequency of preventive maintenance to the flow meter equipment will also be increased.A device history record review for model 30914 lot number 21109141 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14oct2021.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: 13977154
• Report Number: 9616066-2022-00337
• Device Sequence Number: 6032115
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2022

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 Expiration Date: 10/12/2024
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 21109141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/16/2022; 06/17/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 06/10/2022; 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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