MAUDE Adverse Event Report: CAREFUSION, INC LUMBAR PUNCTURE TRAY ADULT 20G; TRAY, SURGICAL, NEEDLE

Model Number	4301C
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pr (b)(4): initial emdr submission.Pictures were provided for evaluation.No physical sample will be returned.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
Material no: 4301c, batch no: 0001361944.It was reported needle stick needle through the shield (bent), verbatim: provider injected patient with lidocaine during a lumbar puncture and went to recap the needle and the needle when through the cap and punctured her left index finger.Recap the needle without the needle going through the safety cap.Safety cap on needle.
Event or Problem Description
Material no: 4301c batch no: 0001361944.The following was reported via email: provider injected patient with lidocaine during a lumbar puncture and went to recap the needle and the needle when through the cap and punctured her left index finger.What was the original intended procedure? recap the needle without the needle going through the safety cap.Per customer's answers via e-mail: the attached form stated that you don¿t have physical samples, we just want to make sure if you have any physical samples that you could return for evaluation? no, the photos sent with the incident is what we have.There are no other samples.Did the person who was stuck with the need seek any medical attention? yes.Would you please be able to provide us with patient identifiers? no.
Additional Manufacturer Narrative
(b)(4).Follow-up emdr for device evaluation: three photos were provided to our quality team for investigation.Through visual inspection, sample analysis of the provided photographs was able to confirm that when the needle was recapped the needle punctured the needle protector.A review of the internal manufacturing device records and raw material history files for reported lot 0001361944 was performed and no recorded quality problems or rejections related to this incident were found, all procedural and functional requirements for product release have been met.Recapping needles is against recommended usage due to this hazard outcome (needle stick injury).Complaint investigation has determined the failure to be use related.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 ADULT 20G
• Common Device Name: TRAY, SURGICAL, NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11293136
• Report Number: 1625685-2021-00013
• Device Sequence Number: 17019219
• Product Code: PWY
• UDI-Device Identifier: 10885403057038
• UDI-Public: (01)10885403057038
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K982269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4301C
• Device Catalogue Number: 4301C
• Device Lot Number: 0001361944
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 02/08/2021
• Supplement Report FDA Received Date: 09/30/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other