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

Lot Number	IV1063
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected tubing has not been returned, they were requested to be return for further investigation.The complaint will be reopened and updated in the event the affected bags involved or additional information becomes available and a follow up mdr will be submitted.
Event or Problem Description
On 06/18/2024, zyno received a report from the customer that they were experiencing multiple failures with the tubing when running propofol through the pump.No patient injury/harm reported.
Additional Manufacturer Narrative
This follow-up 1 report includes corrections to b.4, g.3, g.6, h.2, h.6, h.10, and h.11 because it was discovered that this medwatch report was inadvertently submitted under the incorrect manufacturer (mfr) report #.Refer to h.10 for the correct mfr.Report #.Note: the correct medwatch, listed in h.10, was submitted to fda on the day the inadvertent report was discovered (18-jul-2024).

• 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: 19726449
• Report Number: 3006575795-2024-00494
• Device Sequence Number: 18215435
• 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,Followup
• Report Date (Section B): 07/30/2024

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 Lot Number: IV1063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/30/2024
• 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