MAUDE Adverse Event Report: ZYNO MEDICAL, LLC ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP; IV ADMISTRATION SET

Model Number	BX70072
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/31/2024, zyno received a report from the customer reporting that on 2 separate occasions with 2 different nurses the connection piece on the primary zyno tubing had become disconnected when trying to remove the tubing from the patients iv line.No patient injury/harm reported.
Additional Manufacturer Narrative
The affected product had not been returned; they were requested to be return for further investigation.Testing results were reviewed.It was discovered that there were discrepancies in the test records.Ncr #2024-018 had been initiated to address the discrepancies.This mdr will be reopened and updated in the event the affected product involved or additional information becomes available.

• Brand Name: ADMINISTRATION SET FOR AMBULATORY INFUSION PUMP
• Common Device Name: IV ADMISTRATION 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: frederick lee ; 177 pine street; natick, MA 01760 ; 5086502008
• MDR Report Key: 19581158
• Report Number: 3006575797-2024-00371
• Device Sequence Number: 17989941
• Product Code: FPA
• UDI-Device Identifier: 00814371020570
• UDI-Public: 00814371020570
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K130690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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
• Operator of Device: Health Professional
• Device Model Number: BX70072
• Device Lot Number: 2207006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown