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U.S. Department of Health and Human Services

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

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ZYNO MEDICAL, LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET Back to Search Results
Model Number BX-70071-D
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/20/2020
Event Type  malfunction  
Manufacturer Narrative
Zyno medical has issued a scar (scar 2020-003) to the contract manufacturer regarding the complaint. Used samples returned from the customer couldn't be sent to the contract manufacturer due to the custom control in (b)(6). The samples will be tested by the service provider. Currently, zyno medical is waiting for the investigation results.
 
Event Description
On (b)(6) 2020, a distributor of zyno medical reported a complaint. A user facility representative contacted the distributor on (b)(6) 2020 stating that "an administration set model bx-70071-d lot 1709004 had a dirty spike. " no patient was involved. No medication was used. The device operator was a nurse practitioner. The contract manufacturer of the affected device is podo xingda (tianjin) medical co. Ltd.
 
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Brand NameZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
Type of DeviceIV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL, LLC
177 pine street
natick, ma
Manufacturer (Section G)
ZYNO MEDICAL, LLC
177 pine street
natick, ma
Manufacturer Contact
chaoyoung lee
177 pine street
natick, ma 
3158202
MDR Report Key10209695
MDR Text Key200037655
Report Number3006575795-2020-00007
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/06/2021
Device Model NumberBX-70071-D
Device Catalogue NumberBX-70071-D
Device Lot Number1709004
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/02/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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