MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY PED 22G X1.5 STRL - 4302C; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Model Number	4302C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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).See manufacture narration.
Event or Problem Description
It was reported by the health professional that the tubes are leaking because the cap is not closed tightly.Per email: we're received additional reports of csf specimen tubes leaking.This has already occurred multiple times in our facility this summer.See below for the most recent incident.Incident date: (b)(6) 2021.Staff reported 3 out of the 4 csf tubes were faulty.The caps do not close tightly, allowing specimens to leak out.Per response email: here¿s what i received from our hemonc staff rn¿s this morning: how was the issue resolved? the issue has not resolved.Per entry description " the caps do not close tightly" please clarify, was there a problem with tube or caps threading? the lids do not stay closed, when you twist them shut they end up popping off and the csf is leaking out.It¿s like the cap isn¿t locking in place when it¿s screwed on.Please confirm if there was any patient harm as a result of reported issue.This as caused patient harm in the sense that their csf results tell us if they are still cancer free in the spinal fluid, and if it leaks we have to redo the spinal tap in some situations.Was the specimen contaminated? specimen was not contaminated just leaked out.Multiple specimen tubes are being returned today or tomorrow for investigation.
Event or Problem Description
It was reported by the health professional that the tubes are leaking because the cap is not closed tightly.Per email: we're received additional reports of csf specimen tubes leaking.This has already occurred multiple times in our facility this summer.See below for the most recent incident.Incident date: (b)(6) 2021.Staff reported 3 out of the 4 csf tubes were faulty.The caps do not close tightly, allowing specimens to leak out.How was the issue resolved? the issue has not resolved.Per entry description " the caps do not close tightly" please clarify, was there a problem with tube or caps threading? the lids do not stay closed, when you twist them shut they end up popping off and the csf is leaking out.It¿s like the cap isn¿t locking in place when it¿s screwed on.Please confirm if there was any patient harm as a result of reported issue.This has caused patient harm in the sense that their csf results tell us if they are still cancer free in the spinal fluid, and if it leaks we have to redo the spinal tap in some situations.Was the specimen contaminated? specimen was not contaminated just leaked out.
Additional Manufacturer Narrative
(b)(4) follow-up emdr for device evaluation: one photo and one sample were provided to our quality team for investigation.Through visual inspection, it was observed the cap is loose.When the caps are over-tightened, the caps release and became loose.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001403126 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the quality team's investigation, it was determined that the a probable root cause was evaluated for this investigation as a supplier related issue.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: LUMBAR PUNCTURE TRAY PED 22G X1.5 STRL - 4302C
• 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: 12353487
• Report Number: 1625685-2021-00054
• Device Sequence Number: 19862325
• Product Code: PWY
• UDI-Device Identifier: 10885403057045
• UDI-Public: (01)10885403057045
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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 Model Number: 4302C
• Device Catalogue Number: 4302C
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 02/18/2022
• 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