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

Model Number UNKNOWN

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

The affected device has not yet been returned.

Event Description

Zyno medical received a set physical damage issue from a distributor representative on (b)(6) 2019.A user facility representative reported to this distributor on (b)(6) 2019 that an administration set had broken off during an infusion.The nurse at the time of the event stated "the patient was not harmed but sent to the hospital er to have the picc removed and re-inserted.She stated she did not have the model and lot number of the administration set because the bag was destroyed".The issue was first noticed on (b)(6) 2019.The medication being infused was nafcillin sodium in dextrose solution 2 gm/100ml.The distributor contacted the user facility on (b)(6) 2019 for further details such as model number and device malfunction description and was sent to voicemail.The contract manufacturer of the affected device is unknown.No expiration date or model number has been reported to zyno medical.

Event Description

This is a follow up report for the initially submitted mdr (3006575795-2019-00006).

Manufacturer Narrative

On 05/09/2019, the distributor provided the additional information from the initial reporter about how the event occured: a nurse was attempting to disconnect the set from the picc line and the tubing broke off.On 05/09/2019, zyno medical received the evaluation report from the service provider.The evaluation was completed on 05/08/2019 and the reported issue was confirmed.During testing, visible evidence of a clear break was found at the end of the tubing."it appears as though the tubing was either ripped from the other end by pulling, or possibly had a manufacturing defect that lead to it separating from the rest of the iv set.".

• 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
• MDR Report Key: 8579657
• MDR Text Key: 144153653
• Report Number: 3006575795-2019-00006
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K132841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 65