MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	301629
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while using the bd precisionglide¿ needle, the needle fractured and became lodged inside the patient¿s neck.The following was received by the initial reporter: on (b)(6) 2023, one of customer physicians was performing a routine nerve block procedure using a 27gx1½ bd precisionglide needle.Unfortunately, during the procedure, the needle fractured and became lodged inside the patient¿s neck.This incident resulted in complications for the patient and necessitated immediate medical attention at a local hospital.Customer medical team reacted promptly to address the situation and ensure the patient¿s safety.Add info received on 02-aug-2023: 1st customer response photo evidence: attached are x-ray images taken when the needle was lodged in the patient's neck during a routine spinal accessory nerve block injection.Patient recovery: the patient has recovered.Hospital removed the needle and the patient was discharged home in stable condition with no complications.How the needle broke: the needle broke as during the injection, the 27g 1.5 inch needle snapped at the hub of the needle.The physician attempted to retrieve the end of the needle with sterile clamps however, was unsuccessful.The physician ordered to call ems to transport the patient to the hospital to remove the fragment.
Additional Manufacturer Narrative
H6.Investigation summary: it was reported the needle fractured and became lodged inside a patient¿s neck.To aid in the investigation, three photos were provided for evaluation by our quality team.One photo shows a packaging blister top web.The other two photos appear to be x-rays taken indicating where the needle was in the patient.It appears the needle is complete and possibly became loose from the needle hub.The physical sample analysis would be required to confirm this.No other information could be obtained from the photos.A device history record review was completed for provided material number 301629, lot 2117353.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17546197
• Report Number: 1911916-2023-00583
• Device Sequence Number: 17747951
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: (01)30382903016298
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

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: 301629
• Device Lot Number: 2117353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown