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

Model Number	BX70072
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	08/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of samples to perform the investigation.
Event or Problem Description
On (b)(6) 2019, zyno medical received a complaint from a distributor.The distributor stated that a user facility representative reported that "an administration set model bx-70072 lot # 1810010 was leaking from the bottom joint of the drip chamber".No patient harm or injury was involved.The device operator was a rn.The medication being infused was iron.The user facility representative stated the affected set had been discarded and she would send in 5 sample sets from the same box and lot for evaluation.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2019-00022).
Additional Manufacturer Narrative
Testing of five administration sets from the same lot returned from the customer was performed by the service provider on 09/05/2019.The reported leaking issue couldn't be repeated.On visual inspection, no abnormalities were observed on the five sample iv sets.During the testing, no leaking issue was observed anywhere on the five sample iv sets.The complaint couldn't be confirmed.

• 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: 8925840
• Report Number: 3006575795-2019-00022
• Device Sequence Number: 2129053
• Product Code: FPA
• UDI-Device Identifier: 00814371020570
• UDI-Public: 00814371020570
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 11/26/2021
• Device Model Number: BX70072
• Device Lot Number: 1810010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR