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

Model Number	B2-70070
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Physical Property Issue (3008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer is still in waiting for the arrival of the iv set.
Event or Problem Description
The user reported an iv set leaking issue."we shipped our customer 2 cases of your item # b2-70070.There is an inconsistency in the product you are providing.If you look at the photo attached you can see that there is difference in packaging for the same item.The item on the left is of poor quality and is leaking.The item in the clear packaging on the right is showing no signs of quality concerns.You provided us with the poor quality item on the left." the two types of iv sets are actually manufactured by two different contract suppliers of zyno medical.No patient injury or harm occurred for this case.
Additional Manufacturer Narrative
Zyno medical customer service representative received the update from the customer on 08/15/2017 that the affected device was not available for return.The customer reported that "we have not been able to get the iv sets back from the customer at this point, so i will have to say no to us returning the faulty lot." thus, the manufacturer was unable to confirm the reported issue.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00240).

• 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: 6690609
• Report Number: 3006575795-2017-00240
• Device Sequence Number: 16161018
• Product Code: FPA
• UDI-Device Identifier: 00814371020143
• UDI-Public: 00814371020143
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2017

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: B2-70070
• Device Catalogue Number: B2-70070
• Device Lot Number: 1601007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1