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

Model Number B2-70072

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

On 11/23/2020, zyno medical issued (b)(4) to the contract manufacturer to address the reported issue.Currently, zyno medical is waiting for the response from the contract manufacturer.

Event Description

On 11/13/2020, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 11/12/2020, and stated that an administration set model#: b2-70072; lot#: 20055819, had a pinch clamp that was upside down.No patient was involved.No medication was being infused.The device operator was a registered nurse.On 11/23/3030, the distributor confirmed that the end-user only found one administration set with the inverted pinch clamp in the entire case and that the affected administration set will not be returned.The distributor also provided a picture of the inverted pinch clamp.On 11/24/2020, the distributor provided two additional pictures of the affected set.The contract manufacturer of the affected device is becton, dickinson and company.

Manufacturer Narrative

The contract manufacturer provided the response to the scar on (b)(6) 2021.A review of the layout was performed for the reported model b2-70072.The layout has a fixture which was implemented in (b)(6) 2019 to avoid the "inverted pinch clamp" failure mode.A potential root cause is that the operator did not follow the assembly sequence using the fixture.A trend review of the qns (quality notifications) and complaints were performed in a 1-year period ((b0(6) 2020 to (b)(6) 2021) for model b2-70072.No qns or additional complaints related to the failure mode were found.The complaint is considered as an isolated case.Therefore, no corrective or preventive actions were performed.The complaint will be monitored for track and trend.

Event Description

This is a follow-up for the initially filed mdr (3006575795-2020-00040).

• 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 01760
• MDR Report Key: 10931499
• MDR Text Key: 219371281
• Report Number: 3006575795-2020-00040
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (y/n): N
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2023
• Device Model Number: B2-70072
• Device Catalogue Number: B2-70072
• Device Lot Number: 20055819
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1