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

Model Number	B2-70070
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zyno medical believes that the event was reported to the fda by the user facility in error, because the reported device b2-70070 does not contain the component (injection port) reported as defective.The injection port may be from a needle set that was directly connected to the patient's vein, but zyno medical does not provide such product.Zyno medical was not aware of this event, as there was no such report to us from any sources other than the (b)(6) 2017 letter from the fda.Because the tubing set was discarded by the rn at the user facility and zyno medical does not have the information about the user facility, zyno medical is unable to follow up for any further investigation.
Event or Problem Description
Zyno medical received a letter from fda regarding a medwatch voluntary report (mw5072678) submitted on 10/11/2017.The user reported that "i received report from (8)(6) at patient's dialysis unit that after starting the idpn the injection port on the zyno tubing administration set came loose and began shooting out blood at which point the pump was promptly stopped.The injection port was never used or accessed.They then opened a different package and it was missing the luer lock connector at the end of the tubing, it was just an open tube.They opened a third package and it worked to administer idpn.Zyno medical set (8)(4).Lot 17035394, exp 03/04/2020.Tubing set was discarded by the rn at the unit.".

• Brand Name: ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
• Common Device Name: IV ADMINISTRATION SET
• Manufacturer (Section D): ZYNO MEDICAL LLC; 177 pine street; natick MA 01760
• MDR Report Key: 7009410
• Report Number: 3006575795-2017-00297
• Device Sequence Number: 18956927
• Product Code: FPA
• UDI-Device Identifier: 00814371020143
• UDI-Public: 00814371020143
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K132841
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2020
• Device Model Number: B2-70070
• Device Catalogue Number: B2-70070
• Device Lot Number: 17035394
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1