MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ5307

Device Problems Backflow (1064); Complete Blockage (1094)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that blood backed up into the unspecified bd¿ infusion set primary line due to flow issues. The following information was provided by the initial reporter: "today we had an issue. In the nicu. Piv access ¿ insyte 24 gauge ¿ with a bi-fuse (not the y-site) attached. One line running d-10 at approx. 12 ml/hr and the other line was a med line that was unused and unclamped (not the issue here). An antibiotic syringe was then attached to the med line and the secondary infusion started at approx. 6 ml/hr. Shortly afterward, blood was seen in the primary iv line just past the maxzero iv connector. The nurse thought it was odd but didn¿t stop it at the time and when checking back in an hour, found blood backed all the way up the primary line and into the syringe on the pump. She stopped the abx infusion, i believe disconnected from the syringe, and flushed the tubing but when she did that, the piv infiltrated. It was discontinued. ".

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number. 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.

• Brand Name: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH 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 NJ 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana NJ 22244
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12790844
• MDR Text Key: 280956561
• Report Number: 2243072-2021-02701
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: MZ5307
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• 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