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.
|
|
Manufacturer Narrative
|
The service provider performed visual inspection of the defective administration set sample.The reported issue was confirmed.
|
|
Event Description
|
This is a follow-up for the initially filed mdr (3006575795-2020-00007).
|
|
Manufacturer Narrative
|
The contract manufacturer provided the updated investigation report on 09/03/2020.The contract manufacturer have the following inspections in their current procedure: 1.Inspection in the molding process.2.Inspection during the welding of spike air inlet membrane in the assembly process.3.Light inspection of the drip chamber assembly.The contract manufacturer notified their employees about the issue of the complaint and had refresher training of the procedure on 07/22/2020.
|
|
Event Description
|
This is the third mdr follow up for the initially filed mdr (3006575795-2020-00007).
|
|
Event Description
|
This is the second mdr follow up for the initially filed mdr.
|
|
Manufacturer Narrative
|
The contract manufacturer provided the investigation report on (b)(6) 2020.The possible root cause has been identified as "the spike contacts the lubricant of the injection".Corrective actions taken by the contract manufacturer include: inspection in the molding process inspection during the welding of spike air inlet membrane in the assembly process light inspection of the drip chamber assembly.
|
|
Search Alerts/Recalls
|