MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T PLUS ATRAUMATIC ADULT LP TRAY; TRAY, SURGICAL, NEEDLE

Model Number	4306CWSP
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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.
Event or Problem Description
Material no.: 4306cwsp batch no.: 0001389762.It was reported that the needle broke off in the patient's back.Per attached complaint details: the inquirer below states they were using a spinal tray and the needle broke off in the patient¿s back.They were able to remove the needle using x-ray.The product is attached and i informed the inquirer to hold onto the needle remnants.
Additional Manufacturer Narrative
(b)(4) follow up emdr for device evaluation: one sample was provided to our quality team for investigation.Through visual inspection, the cannula was observed to be broken.Further inspections identified the needle was bent near where the break occurred.A device history review was performed for reported lot, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product is inspected throughout the manufacturing process according to procedure, verifying all critical dimensions are within specification and there is no damage or defects with the product.All records were reviewed and no issues were identified during inspections for the reported lot.Given the bend observed on the cannula, it appears as if the needle may have been repositioned during use which can lead to breakage as observed in the sample received.Based on our investigation and sample evaluation, we cannot identify a root cause related to our manufacturing process at this time.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.H3 other text : see manufacturer narrative.
Event or Problem Description
Material no.: 4306cwsp batch no.: 0001389762.It was reported that the needle broke off in the patient's back.Per attached complaint details: the inquirer below states they were using a spinal tray and the needle broke off in the patient¿s back.They were able to remove the needle using x-ray.The product is attached and i informed the inquirer to hold onto the needle remnants.

• Brand Name: SAFE-T PLUS ATRAUMATIC ADULT LP TRAY
• Common Device Name: TRAY, SURGICAL, NEEDLE
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11506028
• Report Number: 1625685-2021-00024
• Device Sequence Number: 11477183
• Product Code: PWY
• UDI-Device Identifier: 10885403229008
• UDI-Public: (01)10885403229008
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K813338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 4306CWSP
• Device Catalogue Number: 4306CWSP
• Device Lot Number: 0001389762
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention