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); Crack (1135); Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 07/02/2017

Event Type  malfunction  

Manufacturer Narrative

The manufacturer is still in waiting for the arrival of the iv set.

Event Description

The user reported experiencing iv set leaking issue."we have had complaints about fluid leaking out of the filter casing of the 0.2 micron filter tubing (ref: (b)(4)).One time the filter casing cracked open on the side and fluid squirted across the patient's bed and hit the wall.We just finished dispensing tubing from lot 17017533 and switched to a new lot number.I will have to call the nurse to confirm about patient injury.Based on what she told me, there may have been some drug loss, but she mentioned no physical injury.And it happened to several patients because she said other nurses had complained about the same issue.It sounds like it has been happening over several days on several patients.We were alerted of the issue (b)(6) 2017 because they had used up their tubing supply and needed us to send more.By affected iv set, do you want one of the leaking ones or simply one from that lot number that we had been using? for the one patient i have a name for, he was on cefepime.I will call the facility shortly and remind them about the slide clamp being a possible source of the problem.The nurse mentioned that they have had occlusion alerts when they use the same tubing to hang the second ivpb dose of the day." no patient injury or harm occurred for this case.

Manufacturer Narrative

The user-reported leaking issue cannot be confirmed.On 7/22/2017, the user reported to zyno medical's customer service that they did not have any device available to be shipped back to zyno medical for evaluation.The user stated that "i think the best bet is just to close this complaint regarding the leaking from the filter.We have not had any leaking tubing returned to us.".

Event Description

This is a follow-up for the initially filed mdr (3006575795-2017-00241).

• 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: 6690724
• MDR Text Key: 79534050
• Report Number: 3006575795-2017-00241
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00814371020204
• UDI-Public: 00814371020204
• 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,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B2-70072-F
• Device Catalogue Number: B2-70072-F
• Device Lot Number: 17017533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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