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	Insufficient Information (4580)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).
Event or Problem Description
It was reported by customer product has issue.Email verbatim: we have another lumbar puncture tray cat# 4306cwsp that we had an issue with that was related to the recent recall.Lot number 0001424764.If you could please answer the following questions, so that i can open up a new complaint for this.Can you please provide additional details in regards to the issue? manometer would not hold pressure and was leaking at connection between tubing and manometer.Can you please provide the lot number? 0001424764.Can you please provide the material number? cat# 4306cwsp.Can you please provide the date of event? (b)(6) 2022.Would you happen to have photos you can share? no photos.Would you happen to have samples to return? if so, please provide a direct address and phone.We only have one case with the same lot number unopened.What was the impact to the patient? could not get a pressure reading for the provider.How was the issue resolved? patient will need to come back for another procedure, if the provider wants to proceed again.Was there a need to repeat the procedure? unknown at this time.Is there a photo or sample available showing the reported issue for the evaluation? no.Was they able to complete the diagnosis correctly? unknown at this time.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one sample was provided to our quality team for investigation.A visual inspection of the manometer lower opening confirmed the irregular surface of the manometer bottom related to the failure mode of leakage therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001424764 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 manufacture narration.
Event or Problem Description
It was reported by customer product has issue.Email verbatim: we have another lumbar puncture tray cat #4306cwsp that we had an issue with that was related to the recent recall.Lot number 0001424764.If you could please answer the following questions, so that i can open up a new complaint for this.Can you please provide additional details in regards to the issue? manometer would not hold pressure and was leaking at connection between tubing and manometer can you please provide the lot number? 0001424764.Can you please provide the material number? cat #4306cwsp.Can you please provide the date of event? april 25, 2022.Would you happen to have photos you can share? no photos.Would you happen to have samples to return? if so, please provide a direct address and phone.We only have one case with the same lot number unopened.What was the impact to the patient? could not get a pressure reading for the provider.How was the issue resolved? patient will need to come back for another procedure, if the provider wants to proceed again.Was there a need to repeat the procedure? unknown at this time.Is there a photo or sample available showing the reported issue for the evaluation? no.Was they able to complete the diagnosis correctly? unknown at this time.

• 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: 14373051
• Report Number: 1625685-2022-00050
• Device Sequence Number: 16655600
• Product Code: PWY
• UDI-Device Identifier: 10885403229008
• UDI-Public: (01)10885403229008
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2022

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: 4306CWSP
• Device Catalogue Number: 4306CWSP
• Device Lot Number: 0001424764
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/19/2022
• 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 Sex: Unknown