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

Catalog Number MZ1000

Device Problems Backflow (1064); Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd maxzero¿ zero reflux iv connector experience back flow of blood and cracks.The following information was provided by the initial reporter: patients cvc line was inserted on the 8th of september.The following day at approx 1130am noticed that there was back flow of blood into the line attached to the brown lumen despite kvo of the iv line.Removed line and attempted to flush however blood had clotted in the lumen.Upon flushing noticed that there was two interior cracks on the needlefree connector negating the positive pressure of the bung.Entire needle free connector had to be removed and replaced.Due to blood clotted in line empty syringe had to be connected and blood clot aspirated from line prior to flushing line and connecting replacement bung.

Event Description

It was reported that the bd maxzero¿ zero reflux iv connector experience back flow of blood and cracks.The following information was provided by the initial reporter: patients cvc line was inserted on the 8th of september.The following day at approx 1130am noticed that there was back flow of blood into the line attached to the brown lumen despite kvo of the iv line.Removed line and attempted to flush however blood had clotted in the lumen.Upon flushing noticed that there was two interior cracks on the needlefree connector negating the positive pressure of the bung.Entire needle free connector had to be removed and replaced.Due to blood clotted in line empty syringe had to be connected and blood clot aspirated from line prior to flushing line and connecting replacement bung.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 20-oct-2022.H6: investigation summary: one mp1000c-0006 product was received without packaging for investigation the lot number of 21125499 provided by the customer was not recognised in any production records for the maxplus device.The feedback provided by the customer indicates blood backflow issues were detected and upon a close inspection the customer detected cracks on the device.A visual inspection of the returned sample did not identify any cracks or manufacturing defects which could have caused or contributed to the customer's experience.The returned sample was subjected to functional testing by connecting to a 50ml bd plastipak syringe from stock and attempting to flush with fluid; no leakage was detected from the component.The sample was then subjected to pressure testing; again, no leakage was observed from the component throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.The correct lot number was not available and therefore it is not possible to perform a review of the production documentation for the mp1000c-0006 product.In this instance, a definitive root cause could not be identified as testing of the returned sample did not identify any product defects that could have contributed to the customers experience.H3 other text : see h10.

• Brand Name: BD MAXZERO¿ ZERO REFLUX IV 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 Key: 15540584
• MDR Text Key: 306324823
• Report Number: 9616066-2022-01479
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: (01)10885403224782
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K193088
• Number of Events Reported: 1
• 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: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ1000
• Device Lot Number: 21125499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1