MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP-4301C; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4301C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
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.(b)(4).
Event or Problem Description
It was reported by the health professional that there is leakage of spinal fluid at the connection point at the stopcock which does not seal properly.Per email: both of these lot numbers have been pulled from x-ray.When the pressure gage is connected to the tubing from the spinal needle and the spinal fluid begins to flow, it drips from the connection point at the stopcock onto the floor exposing everyone to spinal fluid.This does create patient harm due to loss of pressure for an accurate spinal fluid pressure reading.So the physicians are not receiving accurate information.Therefore this may affect the treatment for the patient.We do have a tray with this last lot number.We continue to have additional lots where the tube does not seal when placed in the stop cock.Lot# 0001415850 is having the same problem.
Event or Problem Description
Material no.: 4301c.Batch no.: 0001415850.It was reported by the health professional that there is leakage of spinal fluid at the connection point at the stopcock which does not seal properly.Per email: both of these lot numbers have been pulled from x-ray.When the pressure gage is connected to the tubing from the spinal needle and the spinal fluid begins to flow, it drips from the connection point at the stopcock onto the floor exposing everyone to spinal fluid.This does create patient harm due to loss of pressure for an accurate spinal fluid pressure reading.So the physicians are not receiving accurate information.Therefore this may affect the treatment for the patient.We do have a tray with this last lot number.We continue to have additional lots where the tube does not seal when placed in the stop cock.Lot# 0001415850 is having the same problem.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.During inspection simulated leakage test performed and confirmed the reported failure mode (leakage/ mating issue).A review of the internal manufacturing device record and raw material history files for the reported lot number 0001415850 was performed, no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.Based on the quality team's investigation, most likely the root cause of this incident is manufacturing related.A corrective action project was opened to further investigate these defects.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 manufacturer here.

• Brand Name: LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP-4301C
• 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: 12353740
• Report Number: 1625685-2021-00055
• Device Sequence Number: 4115377
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K982269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 0001415850
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 11/18/2021
• 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