MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP; LUMBAR PUNCTURE TRAY (ADULT & PEDIATRIC)

Catalog Number	4301C
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by customer that when physician recapping needle, the needle went through cap and stuck physician.Rcc received a complaint via email.When physician recapping needle, the needle went through cap and stuck physician.Physician reported concerned that the needle shouldn't pierce the cap as easily as it did, he tested another type of needle and took extreme pressure to pierce.There were no concerns with physician skill and recapping sinal needles was reported as a common practice.The product was not saved.Customer response on (b)(6) 2024 for fu 2.1.Can you please provide an exact date of event in format dd-mmm-yyyy? 14-07-2024.2.Batch number [1487945] was not found, can you please provide the lot number associated with reported issue? lot number 0001487945.3.When was this defect observed? during or before use? it is our understanding that the event occurred after use when physician recapped needle.4.Did the needle stick injury occur with a contaminated or clean needle? per review of medical record, stick injury occurred with a contaminated needle.5.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.It is our understanding that source testing on patient was performed due to physician exposure to contaminated needle.Results of testing unknown.6.Please describe and include any medical treatment needed as a result? results of testing and/or treatment unknown.7.If possible, could you please provide picture samples for investigation? no known photos obtained.
Additional Manufacturer Narrative
Pr (b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a041001, patient problem code: f11.H10: the lot number for the device was provided.The device history records are currently under review.H10: d4 (expiration date: 07/2024).H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
H10: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001487945 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 available information we are not able to identify a root cause at this time.H11: correction made - adverse type - reported issue is both an adverse event and product problem.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported by customer that when physician recapping needle, the needle went through cap and stuck physician.Verbatim: rcc received a complaint via email.When physician recapping needle, the needle went through cap and stuck physician.Physician reported concerned that the needle shouldn't pierce the cap as easily as it did, he tested another type of needle and took extreme pressure to pierce.There were no concerns with physician skill and recapping sinal needles was reported as a common practice.The product was not saved.Customer response on nov 26, 2024 for fu 2.1.Can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2024.2.Batch number [1487945] was not found, can you please provide the lot number associated with reported issue? lot number 0001487945.3.When was this defect observed? during or before use? it is our understanding that the event occurred after use when physician recapped needle.4.Did the needle stick injury occur with a contaminated or clean needle? per review of medical record, stick injury occurred with a contaminated needle.5.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.It is our understanding that source testing on patient was performed due to physician exposure to contaminated needle.Results of testing unknown.6.Please describe and include any medical treatment needed as a result? results of testing and/or treatment unknown.7.If possible, could you please provide picture samples for investigation? no known photos obtained.

• 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: brett curtice ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 20834414
• Report Number: 1625685-2024-00134
• Device Sequence Number: 3759910
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038(11)220919(17)240731(10)0001487945
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 07/31/2024
• Device Catalogue Number: 4301C
• Device Lot Number: 0001487945
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2022
• 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