MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP; 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	10/11/2021
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).Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001422197, medical device expiration date: 2022-06-30, device manufacture date: 2021-06-26.Medical device lot #: 0001429130, medical device expiration date: 2022-06-30, device manufacture date: 2021-08-16.Medical device lot #: 0001426189, medical device expiration date: 2022-06-30.Device manufacture date: 2021-07-26.
Event or Problem Description
Material no.: 4301c batch no.: 0001422197, 0001429130, 0001426189.It was reported that 3 out of 4 trays leaked.Was there a need to repeat the procedure? no.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? none visible is there a photo or sample available showing the reported issue for the evaluation? attached.If sample is available, please provide address returning from.Na.One point for clarification, although the procedure was not repeated, the requested clinical information (opening and closing pressures) could not be provided to the clinician because of the leakage.Verbatim: 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 3 out of the 4 trays i used.The first leaking tray was lot number 0001429130, exp.Date 2022-06-30, which we opened an additional tray to try to get an accurate opening pressure with lot number 01422197 exp date 2022-06-30 which also leaked.In an additional patient we had the same leaking with lot number 0001426189.Exp date 2022-06-30.These inaccurate manometers reading which is interfering with appropriate patient care.I suspect this product may need to recalled.Hoping you can help to rectify this situation or direct me someone that can.
Event or Problem Description
Material no.: 4301c batch no.: 0001422197, 0001429130, 0001426189.It was reported that 3 out of 4 trays leaked.Was there a need to repeat the procedure? no.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? none visible is there a photo or sample available showing the reported issue for the evaluation? attached.If sample is available, please provide address returning from.Na.One point for clarification, although the procedure was not repeated, the requested clinical information (opening and closing pressures) could not be provided to the clinician because of the leakage.Verbatim: 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 3 out of the 4 trays i used.The first leaking tray was lot number 0001429130, exp.Date 2022-06-30, which we opened an additional tray to try to get an accurate opening pressure with lot number 01422197 exp date 2022-06-30 which also leaked.In an additional patient we had the same leaking with lot number 0001426189.Exp date 2022-06-30.These inaccurate manometers reading which is interfering with appropriate patient care.I suspect this product may need to recalled.Hoping you can help to rectify this situation or direct me someone that can.
Additional Manufacturer Narrative
Pr (b)(4) follow-up emdr for device evaluation: one sample of lot 0001422197 was provided to our quality team for investigation.During inspection simulated leakage test performed and confirmed the reported failure mode leakage.A review of the internal manufacturing device record and raw material history files for the reported lot number 0001422197, 0001429130 and 0001426189 were 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
• 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: 12655964
• Report Number: 1625685-2021-00074
• Device Sequence Number: 13760961
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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: 06/30/2022
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 0001426189
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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