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

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.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Type of Device: IV 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 Key: 10209695
• MDR Text Key: 200037655
• Report Number: 3006575795-2020-00007
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• 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 Received: 06/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/06/2021
• Device Model Number: BX-70071-D
• Device Catalogue Number: BX-70071-D
• Device Lot Number: 1709004
• 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 Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial