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

Model Number	MZ9277
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd microbore extension set experienced spontaneous disconnection.The following information was provided by the initial reporter: the product is not suitable for use because, for example, when rinsing, the syringe pops out, even if it is well inserted in the connector.In addition, when it undergoes a continuous infusion and is carefully attached then it comes off.In addition, various syringes (e.G., luerlock and plain, etc.) are needed to ensure that the drug and fluid reach their destination.
Additional Manufacturer Narrative
Investigation summary: an mz9277 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20067210.From the information provided by the customer it appears that the customer experienced disconnection of an unknown syringe from the maxzero; no further details of the make and model of the syringe were available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 20067210 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mz9277 product.Investigation conclusion: a mz9277 product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20067210.Further information provided by the customer indicates that bounce-back was observed upon connecting the mz9277 product to a syringe.

• Brand Name: BD MICROBORE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12756016
• Report Number: 9616066-2021-52380
• Device Sequence Number: 4326632
• Product Code: FPA
• UDI-Device Identifier: 50885403240797
• UDI-Public: 50885403240797
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K140831
• 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
• Report Date (Section B): 10/14/2021

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: 06/28/2023
• Device Model Number: MZ9277
• Device Catalogue Number: MZ9277
• Device Lot Number: 20067210
• 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: 10/08/2021
• Initial Report FDA Received Date: 11/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2020
• 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