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

Model Number	B2-70072-F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The leaking issue was confirmed.Affected iv sets are under recall #74892.The initial determination by following the company procedures was that this complaint did not constitute an mdr reportable event.This mdr is filed retrospectively as a corrective action to address one of the fda inspection observation made on 08/11/2016.Zyno medical submitted an e-mdr (3006575795-2016-00017_complaint 2015v-039) on 08/23/2016 through the fda's website and received the receipt.But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements.This is a re-submission regarding the same event.
Event or Problem Description
The user reported "we had a bag that leaked at the in-line filter.Patient noticed a puddle on the floor below the iv bag after the treatment.The patient had no adverse effect.We are uncertain as to how much of the actual dose the patient received.".

• 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: 6230492
• Report Number: 3006575795-2016-00017
• Device Sequence Number: 323074
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/03/2017

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-F
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2015
• Initial Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1