MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY PEDIATRIC 21G X2.5; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4304C
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the vial contains a foreign object.Verbatim: the vial contains a foreign object.Appears to be lint or a piece of card board.Un-open right out of the tray.
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.The returned sample was a vial, and the vial contained a small piece of material that looked similar to cardboard; 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 0001452698 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.
Event or Problem Description
It was reported by the customer that the vial contains a foreign object.Verbatim: the vial contains a foreign object.Appears to be lint or a piece of card board.Un-open right out of the tray.

• Brand Name: LUMBAR PUNCTURE TRAY PEDIATRIC 21G X2.5
• 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: 15114318
• Report Number: 1625685-2022-00078
• Device Sequence Number: 20334076
• Product Code: PWY
• UDI-Device Identifier: 10885403057052
• UDI-Public: (01)10885403057052
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 4304C
• Device Catalogue Number: 4304C
• Device Lot Number: 0001452698
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/17/2022
• 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