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

Model Number	BX-70071-D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
Event or Problem Description
On 12/28/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on (b)(6) 2020 and stated "that an administration set model bx-70071-d lot 1811011 is leaking right below the drip chamber." the distributor also reported that "this is the third complaint from this customer of this type.She is told me she is boxing the set up and sending it." the device operator was a registered nurse.Medication being infused was unknown.There was a patient involved.The patient was not harmed or injured.The contract manufacturer of the device is podo xingda ((b)(4)) medical co.Ltd.
Additional Manufacturer Narrative
On 05/17/2021, the distributor report that the affected set was discarded by the user and will not be returned.The reported issue could not be confirmed.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2020-00057).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 11215422
• Report Number: 3006575795-2020-00057
• Device Sequence Number: 4018136
• Product Code: FPA
• UDI-Device Identifier: 00814371020532
• UDI-Public: 00814371020532
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: BX-70071-D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 1811011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 01/22/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1