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

Model Number	B2-70071-DF
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, the distributor confirmed with zyno medical that the administration set was discarded by the user facility and would not be returned for evaluation.The other affected device from the same lot which is reported under mdr #3006575795-2019-00009, would be evaluated by a service provider.
Event or Problem Description
Zyno medical received a needless injection site leaking issue from a distributor representative on (b)(6) 2019.The distributor representative forwarded an email on (b)(6) 2019 from the user facility, which indicated that the user "had two tubing failures today of zyno tubing and that the drugs had to be wasted".It was also reported that "the leaks occured where the needleless injection port enters the iv tubing.She mentioned the set had a filter and was 105" long.She saved one of the tubing and medication sets, while the other was discarded due to having a lot of the patient's blood that leaked and backed up in the tubing".On (b)(6) 2019, the distributor reported more information obtained from the user facility: "after we had those 2 tubing failures we switched to tubing with different lot numbers.We now have approx.7 boxes with the lot # that leaked.I tried to replicate it again with another set and was unable to.I will send you the tubing with the simponi aria bag attached.Let me know if you need anything else.I don't know if this was random or a problem with this lot."the medication infused at the time of the event was simponi aria.No secondary set is used at the time of the event.This report is about the affected device that has been discarded at the user facility site.The other device that is returned is reported under mdr #3006575795-2019-00009.The contract manufacturer of the affected device is becton, dickinson and company.
Event or Problem Description
This is a follow up report for the initially submitted mdr (3006575795-2019-00010).
Additional Manufacturer Narrative
On 05/09/2019, the distributor of zyno medical forwarded this evaluation results to zyno medical.The reported leaking issue at the needless injection site was confirmed.Another affected device from the same lot (reported under mdr #3006575795-2019-00009) was evaluated by a service provider on 05/08/2019.During testing, leakage was found at the bottom of the needleless injection site.

• 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: 8579636
• Report Number: 3006575795-2019-00010
• Device Sequence Number: 1586741
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 04/11/2021
• Device Model Number: B2-70071-DF
• Device Lot Number: 18045625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 103