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

Model Number	B2-70072
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device to be returned.
Event or Problem Description
Zyno medical received an inverted pinch clamp issue from a distributor representative on 04/16/2019.A user facility representative called this distributor and stated that "for the past two weeks, there had been several instances of admin sets that had an inverted pinch clamp.There was no patient involved in any of these issues and no patient came to harm.Issue noticed (b)(6) 2019 by an rn.No medication was infused".The user facility representative also indicated that a few devices with inverted clamps would be sent back to the distributor for evaluation.The contract manufacturer of the affected device is becton, dickinson and company.
Event or Problem Description
This is a follow-up for the initially filed mdr (3006575795-2019-00005).
Additional Manufacturer Narrative
The reported complaint could not be confirmed.The distributor ((b)(4)) provided the following information to zyno medical on (b)(4) 2019: "none of the sets were returned and customer was unresponsive to follow-up phone calls on 4-23-2019, 4-24-2019, 5-3-2019 and 5-20-2019.On each call, (b)(4) was told by the receptionist that (b)(4) would get back to them and she did not.Customer was also unresponsive to follow-up emails sent on 4-16-2019, 4-19-2019, 4-24-2019 and 5-6-2019 asking if she was going to return the set.(b)(4) has therefore closed this customer feedback." since no device was returned, no testing could be performed.On 06/06/2019, zyno medical initiated a voluntary recall on this reported issue, and the affected device is within the scope of this recall.See recall report 3006575795-06/06/2019-001-r for additional information.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8579635
• Report Number: 3006575795-2019-00005
• Device Sequence Number: 13869709
• Product Code: FPA
• UDI-Device Identifier: 00814371020198
• UDI-Public: 00814371020198
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2019

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 Expiration Date: 01/13/2022
• Device Model Number: B2-70072
• Device Lot Number: 19015969
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1