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

Model Number	B2-70072-F
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the affected devices involved in this incident were discarded at the user facility, no testing was performed and zyno medical is unable to confirm the complaint.
Event or Problem Description
On (b)(6) 2018 a distributor of zyno medical forwarded a complaint received from an user facility on (b)(6) 2018 on filter burst issue of the device.There were two administration sets involved in this incident, both of which had the model number of b2-70072-f and the lot number of 17096653.The customer service manager at the user facility reported that both sets burst at the filter site while 2 grams of ceftriaxone were infused, and both sets were used on the same patient.During the second occurrence, the tubing burst at the filter and medication sprayed on to the patient's face and eyes.The director of nursing at the user facility confirmed on (b)(6) 2018 that "no ill effects from resident we immediately flushed eye plus has some eye flush at home husband to bring.We are getting her a eye doctor appt.Just as a extra precaution." the director of nursing also stated that the affected device was discarded and could not be found on (b)(6) 2018.On (b)(6) 2018 the distributor received follow-up information from the nurse director: "have received new tubing.Resident doing fine no ill effects in fact has been in and out building all christmas with husband." the contract manufacturer of the affected device is (b)(4).The other device involved in the incident is reported under mdr 3006575795-2018-00074.

• 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: 8206827
• Report Number: 3006575795-2018-00073
• Device Sequence Number: 2069282
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 09/15/2020
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 17096653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 54