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U.S. Department of Health and Human Services

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

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ZYNO MEDICAL, LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET Back to Search Results
Model Number B2-70072-F
Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2018
Event Type  malfunction  
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 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 (b)(6) with husband. " the contract manufacturer of the affected device is becton, dickinson and company. The other device involved in the incident is reported under mdr 3006575795-2018-00073.
 
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Brand NameZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
Type of DeviceIV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL, LLC
177 pine street
natick MA 01760
Manufacturer (Section G)
ZYNO MEDICAL, LLC
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
5083158202
MDR Report Key8206826
MDR Text Key131944969
Report Number3006575795-2018-00074
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/15/2020
Device Model NumberB2-70072-F
Device Catalogue NumberB2-70072-F
Device Lot Number17096653
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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