MAUDE Adverse Event Report: CAREFUSION, INC PUNCTURE TRAY ADULT 22G X3.5 STRL; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4306C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported that lumbar puncture trays are leaking.Verbatim: hello, please see the attached forms for cedars sinai for some recent failures/complaints with our lumbar puncture trays, item 4306c.Photo below shows where they experienced leakage is occurring.I have samples to send back for both incidents.Customer reports leaking from connection of stopcock out the bottom (picture can be provided to point out where on stopcock), says that the pressure reading reported by the manometer is not reliable on opening or closing.Dr.Says he is uncertain opening closing pressure reading is accurate.Other comments: multiple events occurred on this lot number prior to reporting these two, this is just the first ones they remembered to report and save the stopcock for me.They also think the manometer may be part of the problem but forgot to save them.Have had a total of 15 events on this lot number identical to this event reported.Was there a need to repeat the procedure? - no.Was the specimen contaminated? - no what was done to resolve the issue? ¿ continue the rest of the procedure.Despite the leaking from the connection with the manometer and the stopcock.Was there any cracks or breakage noticed at the connection point? - no, none observed.Please use the attached pre-paid shipping label to return for investigation.¿ sending out tomorrow.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one photo sample was received by our quality team for investigation.Based on the photo evaluation we are unable to verified the failure mode.A device history review could not be completed as the provided batch number was invalid.Based on the quality team's investigation, a growing trend in reports of this failure mode was identified.A corrective action project was opened to further investigate these defects.A voluntary recall pi-21-4292-fa was issue for the leak failure mode in the lumbar puncture trays.Please see attached recall notification letter.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 that lumbar puncture trays are leaking.Verbatim: hello, please see the attached forms for cedars sinai for some recent failures/complaints with our lumbar puncture trays, item 4306c.Photo below shows where they experienced leakage is occurring.I have samples to send back for both incidents.Customer reports leaking from connection of stopcock out the bottom (picture can be provided to point out where on stopcock), says that the pressure reading reported by the manometer is not reliable on opening or closing.Dr.Says he is uncertain opening closing pressure reading is accurate.Other comments: multiple events occurred on this lot number prior to reporting these two, this is just the first ones they remembered to report and save the stopcock for me.They also think the manometer may be part of the problem but forgot to save them.Have had a total of 15 events on this lot number identical to this event reported.Was there a need to repeat the procedure? - no.Was the specimen contaminated? - no.What was done to resolve the issue? ¿ continue the rest of the procedure despite the leaking from the connection with the manometer and the stopcock.Was there any cracks or breakage noticed at the connection point? - no, none observed.

• Brand Name: PUNCTURE TRAY ADULT 22G X3.5 STRL
• 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: 12650147
• Report Number: 1625685-2021-00073
• Device Sequence Number: 1495060
• Product Code: PWY
• UDI-Device Identifier: 10885403057069
• UDI-Public: (01)10885403057069
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4306C
• Device Catalogue Number: 4306C
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 02/28/2022
• 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