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

Model Number	4301CSP
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer black specks are noted in the tubes.Verbatim: srg - vh - 4301csp - lot:0001451109 - black specks are noted in the tubes.This is the third tray that they caught having the specks in the fluid but this one was caught before it was used.
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
It was reported by customer black specks are noted in the tubes.Verbatim: srg - vh - 4301csp - lot:0001451109 - black specks are noted in the tubes.This is the third tray that they caught having the specks in the fluid but this one was caught before it was used.
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 0001451109 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.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: three photos and one sample were provided to our quality team for investigation.Through visual inspection, it was observed that the dark spot embedded in the vial wall ; therefore, the reported failure could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001451109 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 the probable root cause was the supplier materials.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.
Event or Problem Description
It was reported by customer black specks are noted in the tubes.Verbatim: srg - vh - 4301csp - lot:0001451109 - black specks are noted in the tubes.This is the third tray that they caught having the specks in the fluid but this one was caught before it was used.¿ were the other two incidents from the same lot# provided? yes these were from the same lot numbers ¿ would you have any samples available from the lot(s)? i did keep the vial that was last identified as we thought it would be helpful information.¿ were the other two patients impacted from this incident? on the first one there was no realized impact that we are aware of.It was sent off for testing but unsure if the result was due to the spot or not.The last patient we exchanged the tube with another kit that was not concerning.

• 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: 14519027
• Report Number: 1625685-2022-00063
• Device Sequence Number: 14824589
• Product Code: PWY
• UDI-Device Identifier: 10885403107771
• UDI-Public: (01)10885403107771
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 08/15/2022

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: 05/31/2024
• Device Model Number: 4301CSP
• Device Catalogue Number: 4301CSP
• Device Lot Number: 0001451109
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 08/15/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 06/15/2022; 08/15/2022
• 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