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

Model Number	B2-70071-DF-120
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected iv set was not saved by the user.The manufacturer is currently waiting for unopened iv sets with the same lot # from the user to initiate the investigation.A quality alert has been sent to the contract supplier on (b)(6) 2017.
Event or Problem Description
The user reported an iv set leaking issue."we have received complaints from several different facilities all claiming that lot number 16087216 for tpn (total parenteral nutrition) tubing (b2-70071-df-120) is leaking and cannot be used.Patients weren't harmed aside from being uncomfortable, nurse would leave and come back later to find them soaked from where the tubing was leaking.They were unable to pinpoint where the leak was coming from, but it was very fast and they wasted a lot of tpn.".
Additional Manufacturer Narrative
The user-reported issue was not confirmed.Zyno medical performed the investigation testing on two cases of the unused administration sets from the same lot on 09/18/2017.The user-reported leaking issue was not duplicated and no physical damage was found for all sets tested.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2017-00121).

• 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: 6577114
• Report Number: 3006575795-2017-00121
• Device Sequence Number: 557323
• Product Code: FPA
• UDI-Device Identifier: 00814371020174
• UDI-Public: 00814371020174
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/22/2017

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: B2-70071-DF-120
• Device Lot Number: 16087216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 05/18/2017
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1