MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Catalog Number	4301CSP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2023
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.Device problem code: a0504.Patient problem code: f24.
Event or Problem Description
It was reported by the customer that the three-way stopcock from lp tray with lot # 0001450952 - the stopcock was occluded or the holes that allow the fluid to flow were non-patent as the csf had spontaneous and consistent flow without any difficulty but they would not fill the stopcock as usual and therefore would not flow through and allow for pressure measurement with the included manometer but the csf would also not flow out the open port of the stopcock.Lot # 0001452437 - leaked unable to obtain accurate pressure.Verbatim: rcc received a complaint via email.Lot # 0001452437 - leaked unable to obtain accurate pressure further details could be obtained from xxx.
Event or Problem Description
It was reported by the customer that the three-way stopcock from lp tray with lot # 0001450952 - the stopcock was occluded or the holes that allow the fluid to flow were non-patent as the csf had spontaneous and consistent flow without any difficulty but they would not fill the stopcock as usual and therefore would not flow through and allow for pressure measurement with the included manometer but the csf would also not flow out the open port of the stopcock.Lot # 0001452437 - leaked unable to obtain accurate pressure.Verbatim: rcc received a complaint via email.Email(s) attached.The three-way stopcock from lp tray with lot # 0001450952 - the stopcock was occluded or the holes that allow the fluid to flow were non-patent as the csf had spontaneous and consistent flow without any difficulty but the would not fill the stopcock as usual and therefore would not flow through and allow for pressure measurement with the included manometer but the csf would also not flow out the open port of the stopcock.Lot # 0001452437 - leaked unable to obtain accurate pressure further details could be obtained from xxx.
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 number 0001452437 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.We appreciate you taking the time to bring this observation to our attention.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 manufacture narration.

• Brand Name: LUMBAR PUNCTURE TRAY ADULT
• 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: 18111016
• Report Number: 1625685-2023-00108
• Device Sequence Number: 20760749
• Product Code: PWY
• UDI-Device Identifier: 10885403107771
• UDI-Public: (01)10885403107771
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 05/31/2024
• Device Catalogue Number: 4301CSP
• Device Lot Number: 0001452437
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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