MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE SET CSE 27GA WHIT/18GA WEISS; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number	405452
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 405452 batch # 3277668.It was reported by customer that they felt "pop" which felt like dural puncture.However, after removing stylet there was no csf.Entire assembly removed at this point and tip of 4 11/16 in whitacre noted to be broken off.Verbatim: date of event: 7/18/24.Details of event: experienced attending was performing neuraxial.Switched to above packaged item after initial unsuccessful attempt with 3.5 in 27g whitacre.Shortly after switch felt "pop" which felt like dural puncture.However, after removing stylet there was no csf.Entire assembly removed at this point and tip of 4 11/16 in whitacre noted to be broken off.Patient/clinician/procedure impact: case completed after neuraxial performed on contra lateral side.Broken needle removed from paraspinous muscle by interventional radiology.No long term sequelae are expected.How you would like to receive communication: letter/email/call: e-mail (xxx).Contact person: name/address to receive package/phone number: xxx.He previously sent address.Product numbers (skus): lot #: serial #: see attached image for lot/serial numbers of the same product.Actual item was discarded.We also had a 3.5 in 27g whitacre break a few weeks prior which was previously reported.
Additional Manufacturer Narrative
Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Controls in place that could contribute to the reported issues.Per investigation performed, current controls are adequate to mitigate risks associated to the reported failure.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE SET CSE 27GA WHIT/18GA WEISS
• Common Device Name: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19974735
• Report Number: 1625685-2024-00094
• Device Sequence Number: 8586194
• Product Code: BSP
• UDI-Device Identifier: 00382904054526
• UDI-Public: (01)00382904054526(11)231130(17)280930(10)3277668
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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 Catalogue Number: 405452
• Device Lot Number: 3277668
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown