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

Model Number	A2-80071-D
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Iv sets from the same lot number was tested on 01/14/2015.The user reported issue was not duplicated.The iv sets tested performed within specifications.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 (3006575795-2016-00022_(b)(4)) on 09/02/2016 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 customer complained about tubing leakage on (b)(6) 2014.He struggled to explain the problem, but it sounded like he was talking about "the tubing leaking chemo from the end of the tubing even if they are fully engaged the roller clamp and the slide clamp".Our complaint team followed up with the customer on (b)(6) 2014, and the conversation revealed that "there was no leaking but fluid was collecting in the cap on the luer lock".The actual failed iv set was not captured by the customer.The customer returned some unopened iv set from the lots he believed had the issues.No patient injury or harm was involved in this case.

• 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: 6233044
• Report Number: 3006575795-2016-00022
• Device Sequence Number: 16359265
• Product Code: FPA
• UDI-Device Identifier: 00814371020068
• UDI-Public: 00814371020068
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 01/09/2017

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 Expiration Date: 06/01/2017
• Device Model Number: A2-80071-D
• Device Lot Number: 14067149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2015
• Initial Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1