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

Model Number	B2-70071-D
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The failed iv sets were not captured and not returned to the manufacturer for evaluation.But two photos of the iv sets were received, showing the leakage at the bottom of the drip chamber.A supplier corrective action request ((b)(4)) had been issued to address this issue.The complaint was determined as not mdr reportable at the initial determination by following company procedures.This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on 08/11/2016.Zyno medical submitted an e-mdr ((b)(4)) on 10/27/2016 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 reported leaking issues of iv sets."recent sets are leaking where the tubing goes into the drip chamber.There have been at least a dozen and probably more that have not been reported.In fact one nurse stated that she walked past a patient getting fluids and the tubing had completely pulled apart fromthe drip chamber and it was free flowing.As you can imagine this is an emergent situation that we really cannot afford to continue with and still maintain safety for our patients and staff." 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: 6247639
• Report Number: 3006575795-2016-00136
• Device Sequence Number: 19064773
• Product Code: FPA
• UDI-Device Identifier: 00814371020150
• UDI-Public: 00814371020150
• 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): 01/12/2017

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: 04/01/2017
• Device Model Number: B2-70071-D
• Device Lot Number: 1404011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1