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

Model Number A2-80071-D

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2013

Event Type  malfunction  

Manufacturer Narrative

The user-reported issue was confirmed that the tubing was separated at the bottom of the drip chamber.Corrective and preventive action (capa 2013-001) had been issued to address this issue.The complaint was determined as not mdr reportable at the initial determination by following company procedures.This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on (b)(6) 2016.Zyno medical submitted an e-mdr (3006575795-2016-00122_complaint (b)(4)) through the fda's website and received the receipt.But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements.This is a re-submission regarding the same event.

Event Description

The customer reported the iv set tubing was separated at the bottom of the drip chamber.Here are details of event " to recap, levoleucovorin (fusilev) 800mg was placed in a 250ml ns bag with single port tubing to run with oxaliplatin simultaneously, as typical process.When the nurse placed the bag onto the hook, the tubing fell away from the drip chamber, causing a spill onto the nurse, patient and floor.The nurse quickly removed the bag from the pole and inverted, bringing it back to the pharmacy and then proceeded to address the patient, herself and the spill, per protocol.The nursing and pharmacy staffs are concerned going forward with the quality of the tubing.We had problems last week when i spoke with (b)(4) regarding stretching of secondary tubing at the chamber (a2-80075).We do have some concerns and will use extra caution in working with your product." no patient injury or harm was involved in this case.

• 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 ; 5086502008
• MDR Report Key: 6247857
• MDR Text Key: 64737300
• Report Number: 3006575795-2016-00122
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020068
• UDI-Public: 00814371020068
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2-80071-D
• Device Lot Number: 53506JD
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1