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

Catalog Number MZ1000

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.The reported lot# 224379503 was not found for the reported catalog# mz1000.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.D.4.Medical device lot #: unknown.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.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 at least one bd maxzero¿ needleless connector each from lots 224379503 and an unspecified lot had issues with blood leakage during use.The following information was provided by the initial reporter, translated from italian: "in particular, we report the following problem: there is evidence of moderate blood loss".

Manufacturer Narrative

H6: investigation summary a mz1000 sample was not available for investigation.Furthermore, the reported lot number of 224379503 is incorrect and not recognised in the manufacturing records for the maxzero device.The feedback provided by the customer suggests leakage of blood was detected during use of the maxzero; however, no further information was available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the complaint sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.

Event Description

It was reported that at least one bd maxzero¿ needleless connector each from lots 224379503 and an unspecified lot had issues with blood leakage during use.The following information was provided by the initial reporter, translated from italian: "in particular, we report the following problem: there is evidence of moderate blood loss".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17476629
• MDR Text Key: 321530254
• Report Number: 9616066-2023-01661
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: 10885403224782
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132413
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ1000
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• 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
• Patient Sequence Number: 1