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

Model Number B2-70072-F

Device Problems Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975); Component Misassembled (4004)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Zyno medical has not yet received the affected device.

Event Description

Zyno medical received a roller clamp issue and a pinch clamp issue of the administration set from a distributor representative on (b)(6) 2019.The distributor representative forwarded an email on (b)(6) 2019 from the user facility, which stated: "when you open the filtered tubing you will notice the roll clamp in upside down and sequenced wrong.The clamp that 'goes in the pump' is also upside down and sequenced wrong on the tubing." on (b)(6) 2019 the distributor was able to connect with the nurse manager at the user facility where the issue was discovered and who reported that a total of two administration sets were found with the exact same issue.The nurse manager also reported that the device operator was a nurse and the issue was noticed on (b)(6) 2019.The nurse manager confirmed that no patient was involved and no medication was being infused.The nurse manager had one set in possession whereas the other device had been discarded.The distributor also stated the following: "the order and orientation of two parts are incorrect: roller clamp and pinch clamp.The order on the problematic sets was described as follows: spike - back check valve - y-site - roller clamp (skinny end facing y-site) - pinch clamp (tab facing slide clamp) - slide clamp - luer lock.A correct set has the following: spike - back check valve - y-site - pinch clamp (tab facing y- site) - roller clamp (skinny end facing slide clamp) - slide clamp - luer lock." on (b)(6) 2019, the distributor provided the following: "i have emailed (b)(6) to follow-up on the initial phone call with her once on the (b)(6) and again on the (b)(6).In those emails i was asking for follow-up information, asking for a photo of the set, and attaching a shipping label so that she could send us whatever problematic sets she still had.I have received no response so far.I have also attempted to call her yesterday and today, left messages, but so far have received no response.During my original conversation with (b)(6) over the phone, she said that this was not a problem affecting all their sets, but only occasionally they would encounter a set with this issue.When they would find the problem, it would be immediately obvious because the pinch clamp would not fit into its holster inside the door of the pump because it would be upside down.To get it to fit the entire set would have to be upside down".Both affected sets are model b2-70072f and they come from 2 different lots: 18026344 and 18046309.This report is for the device with lot number 18026344.The device with lot number 18046309 is reported in mdr #3006575795-2019-00008.Both bags of these two devices and the one device that the nurse manager has in possession will be returned to the distributor.The contract manufacturer of the affected device is becton, dickinson and company.

Event Description

This is a follow up report for the initially submitted mdr (3006575795-2019-00008).

Manufacturer Narrative

The reported roller clamp inversion issue was not be confirmed.No affected device was returned from the user facility to zyno medical's distributor.The distributor has reached out to the user facility four times between 04/19/2019 and 05/20/2019 via phone and email.

Manufacturer Narrative

In the event section of the first follow-up report of mdr 3006575795-2019-00007, it was incorrectly noted that "this is a follow up report for the initially submitted mdr (3006575795-2019-00008)"; it should have been "this is a follow up report for the initially submitted mdr (3006575795-2019-00007)".

Event Description

This is a second follow up report for the initially submitted mdr (3006575795-2019-00007).

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 8579648
• MDR Text Key: 157343726
• Report Number: 3006575795-2019-00007
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• 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,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2021
• Device Model Number: B2-70072-F
• Device Lot Number: 18026344
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1