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

Catalog Number	4301CSP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that tube/vile #1 provided in this lumbar puncture kit had a foreign body (fb) in it.Initially, customer thought it was just the way the tubes look due to light reflecting.Then as csf began to collect the foreign body began to float and appears as a black speck of debris.The fb then sinks and can be seen at the very bottom of the tube.Central processing was made aware and a specimen note was entered in noting the presence of the foreign body and that this tube should be stored/kept and not utilized for testing unless absolutely necessary.Verbatim: rcc received a complaint via email.Email(s) attached.Tube/vile #1 provided in this lumbar puncture kit had a foreign body (fb) in it.Initially, i thought it was just the way the tubes look due to light reflecting.Then as csf began to collect the fb began to float and appears as a black speck of debris.The fb then sinks and can be seen at the very bottom of the tube.Central processing was made aware and a specimen note was entered in noting the presence of the foreign body and that this tube should be stored/kept and not utilized for testing unless absolutely necessary.
Additional Manufacturer Narrative
(b)(4).Initial emdr submission.Device problem code: a1801.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.H3 other text : see manufacture narration.

• Brand Name: SAFE-T PLUS 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: 18111131
• Report Number: 1625685-2023-00109
• Device Sequence Number: 5556348
• 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: NA
• 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
• Report Date (Section B): 11/10/2023

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: 4301CSP
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/10/2023
• 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