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

Catalog Number	4301C
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr submission.Device problem code: a020101 patient problem code: f24 no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Should you experience any problems with our product, examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
Event or Problem Description
It was reported by the customer that they have performed 2 lumbar punctures in the past 24 hours and have noticed that the new needle (with the black tip) is extremely dull and takes a lot of muscle and pressure to be able to poke through the skin.It almost cannot go through the skin at all.This seems unsafe to have to apply that much pressure, and customer noted that the needle was bent from the amount of force needed to obtain the puncture.Verbatim: i have performed 2 lumbar punctures in the past 24 hours and have noticed that the new needle (with the black tip) is extremely dull and takes a lot of muscle and pressure to be able to poke through the skin.It almost cannot go through the skin at all.This seems unsafe to have to apply that much pressure, and i noted that the needle was bent from the amount of force needed to obtain the puncture.

• 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: 17826006
• Report Number: 1625685-2023-00094
• Device Sequence Number: 20358724
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

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 Catalogue Number: 4301C
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/27/2023
• 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