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

Model Number	305115
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while using bd safety needle the needle broke off in patients neck.Needle was unable to be removed, fluoroscopy, ultrasound, and ct scan performed, surgery recommended.The following information was provided by the initial reporter: customer reporting patient presented to the chronic pain clinic for a trigger point injection.Unfortunately, during the procedure the needle broke inside the patient's neck.Immediate attempts were made at the bedside to retrieve the broken needle but were unsuccessful.With patient consent, retrieval of the foreign object in the fluoroscopy room where both fluoroscopy and ultrasound was used to locate the needle, but not possible.Vascular surgery was consulted and ct scan was recommended sometimes this week for the removal.All needles with the same lot number as the one used were immediately removed from service.Nurse manager and director notified of the event.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd safety needle the needle broke off in patients neck.Needle was unable to be removed, fluoroscopy, ultrasound, and ct scan performed, surgery recommended.The following information was provided by the initial reporter: customer reporting patient presented to the chronic pain clinic for a trigger point injection.Unfortunately, during the procedure the needle broke inside the patient's neck.Immediate attempts were made at the bedside to retrieve the broken needle but were unsuccessful.With patient consent, retrieval of the foreign object in the fluoroscopy room where both fluoroscopy and ultrasound was used to locate the needle, but not possible.Vascular surgery was consulted and ct scan was recommended sometimes this week for the removal.All needles with the same lot number as the one used were immediately removed from service.Nurse manager and director notified of the event.
Additional Manufacturer Narrative
H6: investigation summary: a device history record review was completed by our quality engineer team for provided material number 305115 and lot number 2056622.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.H3 other text : see h10.

• Brand Name: BD SAFETY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17276161
• Report Number: 1911916-2023-00459
• Device Sequence Number: 5281527
• Product Code: FMI
• UDI-Device Identifier: 30382903051152
• UDI-Public: (01)30382903051152
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: Other
• Device Model Number: 305115
• Device Catalogue Number: 305115
• Device Lot Number: 2056622
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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