MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS ATRAUMATIC ADULT LP TRAY; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4306CWSP
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
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 that the manometer seems to be faulty at the insertion to the stopcock (leakage).Verbatim: as indicated in the report, leakage occurred related to the manometer.I spoke with /omitted/, the imaging clinical program coordinator, who described what sounds like a visible defect on the manometer where it connects to the stopcock.She said they compared unused product ¿ pediatric version to an adult version from the same lot number as the item that leaked ¿ and the difference/defect was visible.Per email attachment - ".It appears that out of the box the manometer and valve junction is not sealing adequately.We also tried the manometer with a separate stopcock and that also leaked."what steps were taken to determine if this event was caused by a use error? (e.G.Reviewed instructions for use, confirmed proper training on device usage) - attending physician conducted trouble shooting methods, ultimately disconnected from patient and tested equipment with pf 0.9 ns.Per md ¿reassessed with the manometer, and there was a leak at the junction of the manometer and the stopcock.Even after pushing the two together with significant pressure, and greater force than i had ever used, it still leaked at this junction.After spinning it in circles in the valve with lots of pressure, i was finally able to get it into a position that it wouldn't leak.¿ 29-oct-2021 response: was the physician able to obtain the accurate closing and opening pressure? not in all cases, and those that were obtained were likely inaccurate.What was the impact to the patient? opening and closing pressures on patients being evaluated for ich or iih will have therapy initiated or changed based on pressure findings.These patients potentially were treated incorrectly or misdiagnosed due to inaccuracy.Is there a photo or sample available showing the reported issue? i sent 2 and a video earlier- do you need more? would you happen to have photos you can share? i sent 2 and a video earlier- do you need more? would you happen to have samples to return? if so, we will send a (b)(6) pre-paid label to return samples.Please provide a direct address and phone.I have multiple that have been used, and some that were kept unused from cases not requiring pressure readings.Multiple lot numbers.My contact information is below.
Event or Problem Description
It was reported that the manometer seems to be faulty at the insertion to the stopcock (leakage).Verbatim: as indicated in the report, leakage occurred related to the manometer.I spoke with /omitted/, the imaging clinical program coordinator, who described what sounds like a visible defect on the manometer where it connects to the stopcock.She said they compared unused product ¿ pediatric version to an adult version from the same lot number as the item that leaked ¿ and the difference/defect was visible.As we reach out to report the event, we want to work with you to determine how to proceed with this product (or a replacement product) in future cases.Please provide any information regarding previous events with this product and a plan to work together to conduct the investigation of the defect/adverse reaction.Per email attachment - it appears that out of the box the manometer and valve junction is not sealing adequately.We also tried the manometer with a separate stopcock and that also leaked.What steps were taken to determine if this event was caused by a use error? (e.G.Reviewed instructions for use, confirmed proper training on device usage) - attending physician conducted trouble shooting methods, ultimately disconnected from patient and tested equipment with pf 0.9 ns.Per md ¿reassessed with the manometer, and there was a leak at the junction of the manometer and the stopcock.Even after pushing the two together with significant pressure, and greater force than i had ever used, it still leaked at this junction.After spinning it in circles in the valve with lots of pressure, i was finally able to get it into a position that it wouldn't leak.¿ (b)(6) 2021 response ¿ was the physician able to obtain the accurate closing and opening pressure.¿ not in all cases, and those that were obtained were likely inaccurate ¿ what was the impact to the patient? ¿ opening and closing pressures on patients being evaluated for ich or iih will have therapy initiated or changed based on pressure findings.These patients potentially were treated incorrectly or misdiagnosed due to inaccuracy ¿ is there a photo or sample available showing the reported issue.¿ i sent 2 and a video earlier- do you need more.¿ would you happen to have photos you can share.¿ i sent 2 and a video earlier- do you need more.
Additional Manufacturer Narrative
(b)(4), follow-up emdr for device evaluation: physical sample was provided to our quality team for investigation.During inspection simulated leakage test performed and confirmed the reported failure mode (leakage/ mating issue).As the second lot involved in this incident is unknown, a complaint history review cannot be performed.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 (b)(4) 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.

• Brand Name: SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
• 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: 12759935
• Report Number: 1625685-2021-00083
• Device Sequence Number: 19915161
• Product Code: PWY
• UDI-Device Identifier: 10885403229008
• UDI-Public: (01)10885403229008
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 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: 04/30/2022
• Device Model Number: 4306CWSP
• Device Catalogue Number: 4306CWSP
• Device Lot Number: 0001417843
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 02/10/2022
• 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 Age: 40 YR
• Patient Sex: Female