MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOSHIELD PRESSURE CONTROLLING SYRINGE; CATHETER, IRRIGATION

Model Number	VASOSHIELD PRESSURE CONTROLLING SYRINGE
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Trackwise id (b)(4).
Event or Problem Description
Related to (b)(4).Ssu (b)(6) reported customer complains that the shelf life of the delivery of 5 packs of cvh-5001 vasoshield pressure controlling syringe | is too short < 12 months.A maximum usage time of 13 weeks after delivery is too short.Devices were withdrawn from circulation at the end of the period of use - therefore no use on patients, no impairment and/or damage.
Additional Manufacturer Narrative
It has been determined complaints (tw#: (b)(4)) do not meet the definition of a complaint per mcv00022015.Customer did not accept the devices because the devices they received had a relatively shorter shelf life, the devices were not defective and no adverse event was reported.Therefore, the complaint will be cancelled.
Event or Problem Description
It has been determined complaints (tw#: (b)(4)) do not meet the definition of a complaint per (b)(4).Customer did not accept the devices because the devices they received had a relatively shorter shelf life, the devices were not defective and no adverse event was reported.Therefore, the complaint will be cancelled.

• Brand Name: VASOSHIELD PRESSURE CONTROLLING SYRINGE
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 15153544
• Report Number: 2242352-2022-00663
• Device Sequence Number: 5601911
• Product Code: GBX
• UDI-Device Identifier: 00607567700468
• UDI-Public: 00607567700468
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 07/08/2022
• Device Model Number: VASOSHIELD PRESSURE CONTROLLING SYRINGE
• Device Catalogue Number: C-VH-5001
• Device Lot Number: 25152389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/19/2022
• Date Device Manufactured: 07/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown