MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4301C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 that there is a leak in the manometer.The past 3-4 lumbar trays we¿ve utilized have had a leak in the manometer, this instrument measures intercranial pressure and the leak impacts the accuracy.
Additional Manufacturer Narrative
Pr 4105108 follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001434251 was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation, a growing trend in reports of this failure mode was identified.A corrective action project was opened to further investigate these defects.A voluntary recall pi-21-4292-fa was issue for the leak failure mode in the lumbar puncture trays.Please see attached recall notification letter.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that there is a leak in the manometer.The past 3-4 lumbar trays we¿ve utilized have had a leak in the manometer, this instrument measures intercranial pressure and the leak impacts the accuracy.

• Brand Name: LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
• Common Device Name: LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)
• 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: 13060762
• Report Number: 1625685-2021-00104
• Device Sequence Number: 3888013
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K982269
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 0001434251
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 02/28/2022
• 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