MAUDE Adverse Event Report: CAREFUSION 2200, INC SAFE-T; LUMBAR PUNCTURE TRAY (ADULT AND PEDIATRIC)

Model Number	4306CWSP
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Out of the box, the manometer and valve junction are not sealing adequately.We also tried the manometer with a separate stopcock and that also leaked.Physician conducted troubleshooting methods, ultimately disconnected from patient and tested equipment with pf 0.9 ns (normal saline).Per physician: "reassessed with the manometer, and there was a leak at the junction of the manometer and the stopcock.Even after pushing the two together with significant pressure, and greater force than i had ever used, it still leaked at this junction.After spinning it in circles in the valve with lots of pressure, i was finally able to get it into a position that it wouldn't leak." manufacturer response for lumbar puncture tray (adult pediatric), safe-t (per site reporter).Response from manufacturer: the root cause, as is currently determined, is based on irregularities in the conical surface of the mating area of the manometer.In order to address this issue, our manufacturing team has implemented an update to the manufacturing and inspection plan to require product sampling every 30 minutes.We are also requiring blade maintenance 1x per month at minimum, and developing new visual standards to help better identify product irregularities during 100% visual inspection.Our team has not released an official bound on the total lots impacted, allowing for more time to review any additional product complaints we may receive.

• Brand Name: SAFE-T
• Common Device Name: LUMBAR PUNCTURE TRAY (ADULT AND PEDIATRIC)
• Manufacturer (Section D): CAREFUSION 2200, INC; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 13117513
• Report Number: 13117513
• Device Sequence Number: 14582138
• Product Code: PWY
• UDI-Device Identifier: 10885403229008
• UDI-Public: (01)10885403229008(17)0220430(10)0001417843
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2021
• Report Date (Section F): 12/21/2021

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 Model Number: 4306CWSP
• Device Catalogue Number: 4306CWSP
• Device Lot Number: 0001417843
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 137 KG
• Date Report Sent to FDA: 12/21/2021