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U.S. Department of Health and Human Services

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

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ1000
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2022
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated but not yet began.Upon completion of the investigation a supplemental report will be filled.Device manufacture date: unknown.
 
Event Description
It was reported that the bd maxzero needleless connector experienced blood backflow during infusion.The following information was provided by the initial reporter: the nurse noticed a negligible amount of blood inside the cv route.The clamp may have been loosened or released.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval? yes.D.9.Returned to manufacturer on: 08-apr-2022.H.6.Investigation: two mz1000 samples were received without packaging, however the customer indicated that the complaint samples were from either lot: 21065966 or lot: 21065965.No connecting samples were received to assist the investigation in this instance.As part of the investigation the customer provided some photographs of the affected samples, analysis of the photographs identified that the maxzeros had blood within the components in each instance.The samples were subjected to pressure testing in order to replicate the customer's experience; no leakage was observed from the connection to the syringe in each instance.Furthermore a visual inspection did not identify any damage or defects which could have contributed to the customer's experience.A review of the production records for lot: 21065966 and 21065965 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.
 
Event Description
It was reported that the bd maxzero needleless connector experienced blood backflow during infusion.The following information was provided by the initial reporter: the nurse noticed a negligible amount of blood inside the cv route.The clamp may have been loosened or released.
 
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Brand Name
BD MAXZERO NEEDLELESS CONNECTOR
Type of Device
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 Key14116117
MDR Text Key289322043
Report Number9616066-2022-00377
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/25/2022
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
Device Operator Health Professional
Device Catalogue NumberMZ1000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/22/2022
Initial Date FDA Received04/14/2022
Supplement Dates Manufacturer Received04/25/2022
Supplement Dates FDA Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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