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

Model Number	4306C
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (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 that the stopcock leaks fluid.Verbatim: the 3-way stopcock use to connect the tubing to the manometry column leaks fluid from the bottom.Inaccurate measurements of intrathecal pressure.
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 0001426674 was performed and no recorded quality problems or rejections related to this incident were found.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.H3 other text : see manufacturer here.
Event or Problem Description
It was reported that the stopcock leaks fluid.Verbatim: the 3-way stopcock use to connect the tubing to the manometry column leaks fluid from the bottom.Inaccurate measurements of intrathecal pressure.Was there a need to repeat the procedure? since the intracranial pressure could not be measured accurately and the procedure was ordered for that reason, the procedure would need to be repeated, because no accurate measurement could be obtained.Was the specimen contaminated? no.What was done to resolve the issue? we tried to use a different 3-way than the one used in the kit but it also leaked, because the manometer column could not connect to it properly.Was there any cracks or breakage noticed at the connection point? no crack was noted and the leak appears to be from inside the 3 way itself.This happened with multiple kits, so it is not an issue of one device being damaged.Is there a photo or sample available showing the reported issue for the evaluation? we don¿t have a picture, but it would essentially show csf dripping from the bottom of the 3 way when everything is connected properly.Please provide address sample will be returning from, if available.Loma linda university medical center, radiology department.

• Brand Name: LUMBAR 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: 12740193
• Report Number: 1625685-2021-00079
• Device Sequence Number: 11794002
• Product Code: PWY
• UDI-Device Identifier: 10885403057069
• UDI-Public: (01)10885403057069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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 Expiration Date: 06/30/2022
• Device Model Number: 4306C
• Device Catalogue Number: 4306C
• Device Lot Number: 0001426674
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 02/10/2022
• 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