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

Model Number	A2-80071-DF
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected set is not yet returned to the distributor.
Event or Problem Description
A distributor reported a leaking issue of an administration set to zyno medical on (b)(6) 2018.The distributor received an email on 12/05/2018, who stated that "an a2-80071-df iv set was leaking while the roller clamp was closed".The customer also stated that she did not believe that there was any patient involvement.Date of incident is unknown.Device operator is unknown.The contract supplier of the affected device is becton dickinson.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2018-00069).
Additional Manufacturer Narrative
The reported leaking issue could not be confirmed.On 04/12/2019, zyno medical received an email from the distributor: "the customer has contacted me to say that she has closed her complaint on that set because the customer had not sent in the set and the customer was unresponsive to further requests for the set.".

• 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: 8178633
• Report Number: 3006575795-2018-00069
• Device Sequence Number: 1833555
• Product Code: FPA
• UDI-Device Identifier: 00814371020075
• UDI-Public: 00814371020075
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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: No Information
• Device Expiration Date: 10/05/2020
• Device Model Number: A2-80071-DF
• Device Lot Number: 17105670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1