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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2021
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.Device problem code: a0504.Patient problem code: (b)(4).
Event or Problem Description
It was reported leakage.Verbatim: per customer's response via e-mail 10/26/2021: what is the date you informed bd about this event, is it (b)(6) 2021? the attached document you submitted says (b)(6) 2120? event date (b)(6) 2021- (b)(6) 2021 however not submited til 10/21/21 are the two dates of occurrence as stated on the attached document: (b)(6) 2021-(b)(6) 2021? yes.Have you reported this same complaint in the past, and if so, when? same repeated issue however these are additional lot numbers (example (b)(4)).Was there a need to repeat the procedure? no however inaccurate opening and closing pressure for patient with iih.Was the specimen contaminated? no.What was done to resolve the issue? tightened all connections with continued leaking, pushed in white stopcock with continued leaking.Opened a second tray with new manometer and stopcock with continued leaking despite repeating all of the above interventions.Was there any cracks or breakage noticed at the connection point? no.Is there a photo or sample available showing the reported issue for the evaluation? yes attached.If sample is available, please provide address returning from.Na.The clinician was not able to obtain an accurate opening and closing pressure in the majority of these cases.Due to leaking csf fluid the opening pressure was always inaccurate.A second tray was opened with frequent loss of greater than 1cc of fluid prior to retrial of opening pressure.Often the second tray also leaked, the clinician did measure closing pressure with note indicating inaccuracy.Ultimately the csf fluid removed was an estimation based on patients individual circumstances.In the cat 4301c adult lumbar puncture tray made by carefusion, the neuroradiology team has consistently been finding the stopcocks leaking csf during lumbar punctures, preventing an accurate manometer reading.At times the stop cock leaks at the bottom.At times to stop cock leaks where it connects with the manometer despite tight connections.This occurs in approximately 3 out of 4 trays.I suspect a defect in the stopcocks and/or manometer where it connects to the stopcock.This occurred today with both lumbar punctures i did.Lot number 0001415809, exp.Date 2022-04-30 and lot number 0001422604, exp.Date 2022-06-30.This is making inaccurate manometers reading which is interfering with appropriate patient care.I suspect this product may need to recalled.I have reached out to biomed to try to get the rep that supplies this product and am waiting to hear back.I have also sent a message directly to bd to inform them as they own carefusion.Hoping you can help to rectify this situation or direct me someone that can.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: two photos were provided to our quality team for investigation.Visual examination of the picture provided confirmed the reported failure mode leakage.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001415809 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 leakage verbatim: per customer's response via e-mail 10/26/2021: what is the date you informed bd about this event, is it (b)(6) 2021? the attached document you submitted says (b)(6) 2020? event date: (b)(6) 2021- (b)(6) 2021 however not submited til (b)(6) 2021.Are the two dates of occurrence as stated on the attached document: (b)(6) 2021-(b)(6) 2021? yes.Have you reported this same complaint in the past, and if so, when? same repeated issue however these are additional lot numbers (example (b)(4)).Was there a need to repeat the procedure? no.However, inaccurate opening and closing pressure for patient with iih.Was the specimen contaminated? no.What was done to resolve the issue? tightened all connections with continued leaking, pushed in white stopcock with continued leaking.Opened a second tray with new manometer and stopcock with continued leaking despite repeating all of the above interventions.Was there any cracks or breakage noticed at the connection point? no.Is there a photo or sample available showing the reported issue for the evaluation? yes attached.If sample is available, please provide address returning from.Na.The clinician was not able to obtain an accurate opening and closing pressure in the majority of these cases.Due to leaking csf fluid the opening pressure was always inaccurate.A second tray was opened with frequent loss of greater than 1cc of fluid prior to retrial of opening pressure.Often the second tray also leaked, the clinician did measure closing pressure with note indicating inaccuracy.Ultimately the csf fluid removed was an estimation based on patients individual circumstances.In the cat 4301c adult lumbar puncture tray made by carefusion, the neuroradiology team has consistently been finding the stopcocks leaking csf during lumbar punctures, preventing an accurate manometer reading.At times the stop cock leaks at the bottom.At times to stop cock leaks where it connects with the manometer despite tight connections.This occurs in approximately 3 out of 4 trays.I suspect a defect in the stopcocks and/or manometer where it connects to the stopcock.This occurred today with both lumbar punctures i did.Lot number 0001415809, exp.Date 2022-04-30 and lot number 0001422604, exp.Date 2022-06-30.This is making inaccurate manometers reading which is interfering with appropriate patient care.I suspect this product may need to recalled.I have reached out to biomed to try to get the rep that supplies this product and am waiting to hear back.I have also sent a message directly to bd to inform them as they own carefusion.Hoping you can help to rectify this situation or direct me someone that can.

• 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: 12745237
• Report Number: 1625685-2021-00080
• Device Sequence Number: 19951035
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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: 04/30/2022
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 0001415809
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 11/03/2021
• Supplement Report FDA Received Date: 03/23/2022
• 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