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

Catalog Number MZ1000

Device Problem Backflow (1064)

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

Event Date 03/19/2022

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated but not yet began.Upon completion of the investigation a supplemental report will be filled.Device manufacture date: unknown.

Event Description

It was reported that the bd maxzero needleless connector experienced blood backflow during infusion.The following information was provided by the initial reporter: the nurse noticed a negligible amount of blood inside the cv route.The clamp may have been loosened or released.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval? yes.D.9.Returned to manufacturer on: 08-apr-2022.H.6.Investigation: two mz1000 samples were received without packaging, however the customer indicated that the complaint samples were from either lot: 21065966 or lot: 21065965.No connecting samples were received to assist the investigation in this instance.As part of the investigation the customer provided some photographs of the affected samples, analysis of the photographs identified that the maxzeros had blood within the components in each instance.The samples were subjected to pressure testing in order to replicate the customer's experience; no leakage was observed from the connection to the syringe in each instance.Furthermore a visual inspection did not identify any damage or defects which could have contributed to the customer's experience.A review of the production records for lot: 21065966 and 21065965 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customer¿s experience.

Event Description

It was reported that the bd maxzero needleless connector experienced blood backflow during infusion.The following information was provided by the initial reporter: the nurse noticed a negligible amount of blood inside the cv route.The clamp may have been loosened or released.

• 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: 14116117
• MDR Text Key: 289322043
• Report Number: 9616066-2022-00377
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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 Number: MZ1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/14/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/13/2022
• 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