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	12/21/2021
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 bd alaris¿ extension set had blockage issues.The following information was provided by the initial reporter: "tubing does not allow pushing of fluids".
Additional Manufacturer Narrative
Investigation summary: one sample (model #30914) and one syringe were returned by the customer.It was reported that the tubing does not allow pushing of fluid.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was connected to the returned syringe and attempted to be flushed with saline, and then connected to a 10ml bd syringe and attempted to be flushed with water.The set was unable to be flushed during both attempts.There seemed to be an occlusion at the top connector of the tubing.Further examination under magnification showed an occlusion.The complaint can be verified.A quality notification has been sent to the manufacturer.Further investigation by the manufacturer identified several principal root causes.The first root cause is a lack of set air sweep time in operation 1.It was detected during the assembly of the set that the air sweep time was not enough as marked in sws 30914 dir tahiti-10000096422, rev.27, operation 1, which indicates that the set should be left in the air hose or fixture pe 2249, until the new assembly is carried out, ensuring the time of air sweeping.The second root cause is a lack of rest time.Sws 30914 dir tahiti-10000096422, rev.27, operation 2 indicates that a kanban of 50 pieces must be made before testing the flow meter.However, it is necessary to ensure that the first piece is the first piece out, to have the longest resting time.It was also determined that the use of an analog flow meter is not the appropriate detection method because it does not present a standardized reading.It was also found that it is necessary to increase the frequency of preventative maintenance of the flow meter.A device history record review for model 30914 lot number 21099091 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported bd alaris¿ extension set had blockage issues.The following information was provided by the initial reporter: "tubing does not allow pushing of fluids.".

• 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: 14145544
• Report Number: 9616066-2022-00419
• Device Sequence Number: 15025708
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/13/2022

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/12/2022
• 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