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U.S. Department of Health and Human Services

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

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXZERO NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ1000
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 20075058. Medical device expiration date: unknown. Device manufacture date: unknown. Medical device lot #: 21015542. Medical device expiration date: unknown. Device manufacture date: unknown. Medical device lot #: 21015540. Medical device expiration date: unknown. Device manufacture date: unknown. Medical device lot #: 20085530. Medical device expiration date: unknown. Device manufacture date: unknown. Medical device lot #: 20075926. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: one mz1000 sample was received without packaging for investigation. The customer feedback indicates that the affected product was from either lot 21015542, 21015540, 20085530, 20075926 or 20075058. A visual inspection of the returned maxzero identified a crack on the female luer adaptor (fla) of the component (appendix 1). During functional testing leakage was observed from the crack. The details of this feedback were forwarded to the manufacturing site for investigation. They performed an in-depth investigation in order to determine a potential root cause for cracks of this nature; during the investigation no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage. A review of the production records for lot 21015542, 21015540, 20085530, 20075926 and 20075058 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. 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. In this instance the customer confirmed that the damage was observed after the maxzero had been in use for one and a half months; please note that the dfu for the maxzero states "change according to facility protocol or in accordance with currently recognized guidelines for iv therapy, such as every 7 days or 200 activations". A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mz1000 product in the past 12 months.
 
Event Description
It was reported that maxzero needleless connector was damaged, but still operable. The following information was provided by the initial reporter: "this is a report about a cracked mz1000. ".
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
MDR Report Key12633549
MDR Text Key276597644
Report Number9616066-2021-52232
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ1000
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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