MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD IV EXTENSION SETS; 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	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 2 bd iv extension sets would not prime or flush.The following information was provided by the initial reporter: on both occasions would not flush/prime.
Event or Problem Description
It was reported that 2 bd iv extension sets would not prime or flush.The following information was provided by the initial reporter: on both occasions would not flush/prime.
Additional Manufacturer Narrative
H6: investigation summary 1 sample for model 30914 and lot number# 22049066 was returned for investigation by customer.The set was examined for defects and abnormalities for flow issues and was observed that it was not able to flush/prime when the tube was connected to a 10 ml bd syringe filled with water and the set was attempted to be flushed.The set was not flushed.Attempted to prime with the cap on and off at the end and was still unable to prime.The customer complaint that on two occasions they would not flush/prime could be replicated.Also performed close observation under microscope by separating the tubing and it comes under visual observation that there is excessive solvent inside the tube and this may be the cause of complete occlusion.The root cause of flow issues - fluid blockage- complete occlusion occurrence could be determined because of excessive solvent.According to the investigation and previous investigation performed, the principal root causes are: methods: lack of set air sweep time in operation 2.It was detected during the assembly of the set that the air sweep time was not enough as marked in operation , which indicates that the set should be left in the air hose or fixture until the new assembly is carried out, ensuring the time of air sweeping.Lack of rest time.It 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 in is the first piece out, to have the longest resting time.A device history record review for model #30914 and lot number 22049066 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 21apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot # 22049066.

• Brand Name: BD IV EXTENSION SETS
• 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: 15164752
• Report Number: 9616066-2022-01050
• Device Sequence Number: 4717354
• Product Code: FPA
• UDI-Device Identifier: 50885403233317
• UDI-Public: 50885403233317
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 08/23/2022

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: 04/05/2025
• Device Model Number: 30914
• Device Catalogue Number: 30914
• Device Lot Number: 22049066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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