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

Model Number	A2-80075
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/15/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user-reported separation issue was confirmed.A supplier corrective action request (scar-006) 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 (b)(4) 2016.Zyno medical submitted an e-mdr (3006575795-2016-00118_complaint (b)(4)) on 10/26/2016 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 that "the tubing came off the drip chamber", and "fortunately there was water in the bag which went everywhere when the tubing came off and not chemo".No patient 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: 6247823
• Report Number: 3006575795-2016-00118
• Device Sequence Number: 16513304
• Product Code: FPA
• UDI-Device Identifier: 00814371020136
• UDI-Public: 00814371020136
• 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
• Report Date (Section B): 01/13/2017

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: A2-80075
• Device Lot Number: 57065KS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2013
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2013
• 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