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

Model Number VASOSHIELD PRESSURE CONTROLLING SYRINGE

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Trackwise id: (b)(4).

Event Description

Related to: (b)(4).Ssu germany 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 12 months.A maximum usage time of 13 weeks after delivery is too short.Devices were withdrawn from circulation at the end of the period of use - therefore no use on patients, no impairment and/or damage.

Event 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.

Manufacturer Narrative

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
• Type of Device: 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: 15153709
• MDR Text Key: 302789670
• Report Number: 2242352-2022-00666
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00607567700468
• UDI-Public: 00607567700468
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/18/2022
• Date Device Manufactured: 07/08/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1