MAUDE Adverse Event Report: MANOMETER TRAY STERILE 10/BX - 4330; MANOMETER, BLOOD-PRESSURE, VENOUS

Model Number	4330
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) initial emdr submission.(b)(4).No photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported manometers that are used are leaking when connected to the stopcock.Email verbatim: "good afternoon, the manometers that are used in the department of neuroradiology, lot# 000141691, are leaking when connected to the stopcock.This may cause an incorrect reading when measuring pressures.Reference # (b)(4).Description is "manometer, 550 ml, three  way stopcock.Company is carefusion.Hospital storeroom bin # is (b)(4).We do have another lot that does not leak, # (b)(4).But we only have 2.I will need more shortly, but not sure what lot will come up from storeroom.I am thankful for any guidance you can give me.Thank you".

• Brand Name: MANOMETER TRAY STERILE 10/BX - 4330
• Common Device Name: MANOMETER, BLOOD-PRESSURE, VENOUS
• MDR Report Key: 12536485
• Report Number: 1625685-2021-00064
• Device Sequence Number: 1337269
• Product Code: KRK
• UDI-Device Identifier: 10885403076145
• UDI-Public: (01)10885403076145
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4330
• Device Catalogue Number: 4330
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 09/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other