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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 Problems Crack (1135); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2022
Event Type  malfunction  
Event Description
It was reported that the bd maxzero¿ needleless connector was cracked and leaked.The following information was provided by the initial reporter: cracks.The use of max zero was started, an intravenous drip leakage was confirmed by a nurse on call.
 
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 Description
It was reported that the bd maxzero¿ needleless connector was cracked and leaked.The following information was provided by the initial reporter: cracks.The use of max zero was started, an intravenous drip leakage was confirmed by a nurse on call.
 
Manufacturer Narrative
Investigation summary: a mz1000 sample was received without packaging for investigation; the lot number of the complaint product was also reported unknown.The feedback provided by the customer indicates the maxzero product was cracked and this resulted in leakage of medication during a soldem, meylon and uromitexan infusion; furthermore the leakage was observed after approximately 17 days of infusion.No connecting products were received to assist the investigation.Analysis of the photographs provided by the customer confirms the customer's experience with a crack observed at the female luer adaptor (fla) of the maxzero; furthermore a visual inspection of the returned sample confirmed the crack at the fla of the maxzero.The returned sample was then subjected to pressure testing in order to replicate the customer's experience; leakage was observed from the crack to the fla.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Previous investigations have been unable to determine a potential root cause for the customer's experience; no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.Although a definitive root cause could not be determined in this instance, previous investigations have confirmed similar damage can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.
 
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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 Key14639529
MDR Text Key293612447
Report Number9616066-2022-00692
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/20/2022
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
Date Returned to Manufacturer06/02/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/12/2022
Initial Date FDA Received06/08/2022
Supplement Dates Manufacturer Received06/20/2022
Supplement Dates FDA Received07/18/2022
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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