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	10/15/2021
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).Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001414358, medical device expiration date: 2022-03-31, device manufacture date: 2021-04-27.Medical device lot #: 0001417243, medical device expiration date: 2022-04-30, device manufacture date: 2021-05-19.
Event or Problem Description
It was reported that clinicians have reported there's leakage which prevents them from obtaining an accurate opening pressure.Verbatim: defect reported at the base of the manometer where the stop cock is connected, clinicians have reported there's leakage which prevents them from obtaining an accurate opening pressure.It's affecting 2 lot numbers but not consistently.I do not believe this can issue is attributed to user error, the manometer has been securely placed in the stop-cock.Were there any adverse events as a result of the reported failure? unknown but not reported.
Additional Manufacturer Narrative
(b)(4) 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 numbers 0001417243 and 0001414358 were 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 clinicians have reported there's leakage which prevents them from obtaining an accurate opening pressure.Defect reported at the base of the manometer where the stop cock is connected, clinicians have reported there's leakage which prevents them from obtaining an accurate opening pressure.It's affecting 2 lot numbers but not consistently.I do not believe this can issue is attributed to user error, the manometer has been securely placed in the stop-cock.Were there any adverse events as a result of the reported failure? unknown but not reported.Is a sample available to return for evaluation? no, it was discarded onsite at the time of the event.
Event or Problem Description
It was reported that clinicians have reported there's leakage which prevents them from obtaining an accurate opening pressure.Verbatim: defect reported at the base of the manometer where the stop cock is connected, clinicians have reported there's leakage which prevents them from obtaining an accurate opening pressure.It's affecting 2 lot numbers but not consistently.I do not believe this can issue is attributed to user error, the manometer has been securely placed in the stop-cock.09-nov-21 - response - ¿ were there any adverse events as a result of the reported failure? unknown but not reported.¿ is a sample available to return for evaluation? no, it was discarded onsite at the time of the event.
Additional Manufacturer Narrative
Pr 3895139 follow-up emdr for device evaluation: two trays from lot number 0001415038 and one tray from lot number 0001417243 were provided to our quality team for investigation.Through visual inspection, it was observed that the manometer bottoms were missing from the trays therefore functional testing could not be performed.The reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 0001417243, 0001414358 and 0001415038 were 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.Medical device lot #: 0001415038.Medical device expiration date: 2022-03-31.Device manufacture date: 2021-05-04.

• 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: 12860911
• Report Number: 1625685-2021-00093
• Device Sequence Number: 4353196
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2023

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: 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): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 02/10/2022; 11/04/2023
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/10/2022; 11/07/2023
• 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