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

Model Number	B2-70072
Medical Device Problem Codes	Leak/Splash (1354); Device Operates Differently Than Expected (2913); Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical was unable to confirm the user-reported complaint.The affected set was discarded by the user and was not sent back to the manufacturer for evaluation.Zyno medical is waiting for the customer to confirm if there is any available iv set to be sent in for evaluation.
Event or Problem Description
The user reported that an iv set leaking issue."most of the offices only experienced leaking from the upper y site and back check valve issues.There were no patient injuries but the leaks did cause chemo spills.Those sets were immediately destroyed.".
Additional Manufacturer Narrative
Zyno medical's customer service employee reached out to the customer to confirm if there would be any available iv set to be sent back to the manufacturer for evaluation with no response.The user-reported issue could not be confirmed.A quality alert was sent to the contract supplier on 05/11/2017.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00119).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 6560038
• Report Number: 3006575795-2017-00119
• Device Sequence Number: 11035114
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: B2-70072
• Device Lot Number: 1604015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2017
• Supplement Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1