MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP - 4301C; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4301C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
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
Material no.: 4301c batch no.: 0001417243.It was reported that during lumbar puncture, a leak was noticed.Verbatim: this r-sbar is being submitted as an informational tool regarding an unusual occurrences: situation :member received inaccurate opening and closing pressure during her lumbar puncture due to a faulty lot of manometers and or stopcocks in our lumbar puncture trays.Background: during the member's lumbar puncture while obtaining opening pressures dr.(b)(6) and i noticed a leak of csf fluid between the manometer and stopcock.I opened a new tray and dr.(b)(6) exchanged the old stopcock for the new one, but there was still a leak.He then proceeded to exchange the manometer and we found there was still a leak.Assessment: carefusion adult lumbar puncture trays cat.4301c lot no: 0001417243 contain faulty manometers and or faulty stopcocks.Recommendation/request: per the ordering neurologist the member will need another lumbar puncture to obtain accurate opening and closing pressures.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.During inspection simulated leakage test performed and confirmed the reported failure mode (leakage/ mating issue).A review of the internal manufacturing device record and raw material history files for the reported lot number 0001417243 was performed, no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.Based on the quality team's investigation, the root cause of this incident is manufacturing related.A corrective action project was opened to further investigate these defects.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
Material no.: 4301c; batch no.: 0001417243.It was reported that during lumbar puncture, a leak was noticed.Verbatim: this r-sbar is being submitted as an informational tool regarding an unusual occurrences: situation :member received inaccurate opening and closing pressure during her lumbar puncture due to a faulty lot of manometers and or stopcocks in our lumbar puncture trays.B: background: during the member's lumbar puncture while obtaining opening pressures dr.(b)(6) and i noticed a leak of csf fluid between the manometer and stopcock.I opened a new tray and dr.(b)(6) exchanged the old stopcock for the new one, but there was still a leak.He then proceeded to exchange the manometer and we found there was still a leak.A: assessment: carefusion adult lumbar puncture trays cat.4301c; lot no: 0001417243; contain faulty manometers and or faulty stopcocks.R: recommendation/request: per the ordering neurologist the member will need another lumbar puncture to obtain accurate opening and closing pressures.

• Brand Name: LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP - 4301C
• 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: 12310306
• Report Number: 1625685-2021-00051
• Device Sequence Number: 14469822
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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 Expiration Date: 04/30/2022
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 0001417243
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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