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 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 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
• Type of Device: IV 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 Key: 8206827
• MDR Text Key: 132211409
• Report Number: 3006575795-2018-00073
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• 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 Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial