MAUDE Adverse Event Report: CAREFUSION, INC 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	08/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by the sales representative that the product leaked.Product leaking.Per response email: the manometer was leaking at the connection to the stopcock.There were no cracks or breaks in manometers that could be visualized.Initially we tried using another manometer , which did the same thing.We then had to use more force for a tighter seal.That seemed to resolve the issue but then it is difficult to disconnect manometer/stopcock.The impact to patient is that if it leaks, we cannot record an accurate opening pressure and many of these patients have lumbar punctures ordered almost exclusively for opening pressure.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: one photo of the package was provided to our quality team for investigation.A review of the internal manufacturing device records and raw material history files for the reported lot number: 0001414251 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text: see manufacturer here.
Event or Problem Description
It was reported by the sales representative that the product leaked.Product leaking.Per response email: the manometer was leaking at the connection to the stopcock.There were no cracks or breaks in manometers that could be visualized.Initially we tried using another manometer , which did the same thing.We then had to use more force for a tighter seal.That seemed to resolve the issue but then it is difficult to disconnect manometer/stopcock.The impact to patient is that if it leaks, we cannot record an accurate opening pressure and many of these patients have lumbar punctures ordered almost exclusively for opening pressure.

• Brand Name: MANOMETER TRAY STERILE 10/BX - 4330
• Common Device Name: MANOMETER, BLOOD-PRESSURE, VENOUS
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 12353491
• Report Number: 1625685-2021-00053
• Device Sequence Number: 3794921
• Product Code: KRK
• UDI-Device Identifier: 10885403076145
• UDI-Public: (01)10885403076145
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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 Expiration Date: 03/31/2024
• Device Model Number: 4330
• Device Catalogue Number: 4330
• Device Lot Number: 0001414251
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 02/18/2022
• 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
• Patient Sex: Unknown