MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM; IV ADMINISTRATION SET

Model Number B2-70072

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/04/2023

Event Type  malfunction  

Event Description

As soon as the tubing was connected, blood began flowing back up into the line.Fluid then began leaking from the injection site.Medication was unknown.Volume to be infused was unknown.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• Manufacturer (Section G): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• Manufacturer Contact: lorraine hanley ; 177 pine street; natick, MA 01760 ; 5083158230
• MDR Report Key: 17487964
• MDR Text Key: 320712344
• Report Number: 3006575795-2023-00086
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 814371020198
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2023

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: Lay User/Patient
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 22115097
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/09/2023
• 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: Unknown
• Patient Sequence Number: 1