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

Model Number	B2-70071-DF120
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer will not return any of the affected administration sets for investigation.The complaint couldn't be confirmed.Use error might contribute to the event as reported by the user.
Event or Problem Description
On (b)(6) 2019, a distributor of zyno medical reported an administration set leaking issue.A user facility representative contacted the distributor stating that an administration set model b2-70071-df120 lot number 16095885 leaked from the 1.2-micron filter.This was one of 3 occurrences at a long term care facility.She stated that typically when it occurred the resident heard it pop and then called the nurse.She stated that they were following protocol by being sure to use the 1.2-micron filter.She also stated she will contact the facility to ask if they saved any of the sets that leaked and if they could send a photo of any of them.The distributor followed up with the user facility representative for further information, advising that they not use sets on their expiration month, and did not receive a response.On (b)(6) 2019, the distributor provided further information about the complaint.The distributor got a call from the number (b)(6) from a pharmacist at the user facility, who stated it is possible that in this case the nurses mixed up the 1.2-micron filter with the 0.2-micron filter sets, despite their being different colors.The pharmacist wanted to be sure there had not been any other reports of the 1.2 micron filter bursting before he reminded the nurses to use the sets with the correct filter.The distributor assured the pharmacist that no other recent reports of the nature had been received by the distributor.The pharmacist stated no sets would be returned to the distributor from this or other previous incidents of this nature but that in the future they would take a photo and send in the sets.The device operator was a licensed practical nurse.The medication being infused was total parenteral nutrition with lipids.A patient was involved but not harmed or injured.The contract manufacturer of the affected device is becton, dickinson and company.

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL, LLC; 177 pine street; natick MA 01760
• MDR Report Key: 9115704
• Report Number: 3006575795-2019-00028
• Device Sequence Number: 1912875
• Product Code: FPA
• UDI-Device Identifier: 00814371020174
• UDI-Public: 00814371020174
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 09/01/2019
• Device Model Number: B2-70071-DF120
• Device Lot Number: 16095885
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1