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

Catalog Number MZ1000

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 05/11/2022

Event Type  malfunction  

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, translated from (b)(6) to english: cracks.Started using max zero, confirmed an intravenous drip leak by a nurse.

Event Description

It was reported that the bd maxzero¿ needleless connector was cracked and leaked.The following information was provided by the initial reporter, translated from japanese to english: cracks.Started using max zero, confirmed an intravenous drip leak by a nurse.

Manufacturer Narrative

H6: investigation summary.A mz1000 sample was received without packaging for investigation and 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 the leakage of medication during a soldem, meylon and uromitexan infusion; furthermore the leakage was observed after approximately one month of use.No connecting products were received to assist the investigation.Analysis of the photographs provided by the customer does not confirm the customer's experience of leakage; however, a visual inspection of the returned sample does reveal a small crack at the edge of the female luer adaptor.The returned sample was then subjected to pressure testing in order to replicate the customer's experience; leakage was observed from the crack on the female luer adaptor.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.Please note the directions for use of the maxzero recommends the following "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.H3 other text : see h10.

• 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 Key: 14634940
• MDR Text Key: 293612954
• Report Number: 9616066-2022-00688
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MZ1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• 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 Number: 1