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

Catalog Number	305128
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
Additional Manufacturer Narrative
A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.D.4.Medical device expiration date: unknown.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd precisionglide¿ needle broke off into the patient after injecting dilute contrast.A general surgeon was called in to remove the needle, but the first attempt was unsuccessful.A second attempt with fluoroscopic guidance was successful at removing the broken needle, and two x-rays were performed to monitor the patient's condition.The following information was provided by the initial reporter: "adolescent girl with byler's disease and complex hx with ewings sarcoma of the chest wall.Patient presented today to ir for a ct guided right chest wall lesion biopsy.Attending was biopsying a small pleural nodule in this patient with history of ewings sarcoma.To avoid puncturing the lung and causing a pneumothorax, injected dilute contrast into the pleural space to push the lung away (hydrodissection).Used a small needle (30 gauge).When trying to pull out the needle, it snapped off at the hub leaving one piece extending through the nodule into the pleural space.It was not protruding through the skin.Unsuccessful at removal of needle, general surgery came to the ct scanner.While waiting for surgery, md proceeded with the biopsy.Surgeon attempted to remove the needle fragment in the ct scanner but was unsuccessful and felt fluoroscopy would be needed.Surgery successful in removing the needle with fluoroscopic guidance.A chest x-ray showed no pneumothorax or other complication.The patient recovered uneventfully, and a repeat chest x-ray 2 hours post removal showed no pneumothorax.Was discharged home in stable condition.
Event or Problem Description
It was reported that the bd precisionglide¿ needle broke off into the patient after injecting dilute contrast.A general surgeon was called in to remove the needle, but the first attempt was unsuccessful.A second attempt with fluoroscopic guidance was successful at removing the broken needle, and two x-rays were performed to monitor the patient's condition.The following information was provided by the initial reporter: "adolescent girl with byler's disease and complex hx with ewings sarcoma of the chest wall.Patient presented today to ir for a ct guided right chest wall lesion biopsy.Attending was biopsying a small pleural nodule in this patient with history of ewings sarcoma.To avoid puncturing the lung and causing a pneumothorax, injected dilute contrast into the pleural space to push the lung away (hydrodissection).Used a small needle (30 gauge).When trying to pull out the needle, it snaped off at the hub leaving one piece extending through the nodule into the pleural space.It was not protruding through the skin.Unsuccessful at removal of needle, general surgery came to the ct scanner.While waiting for surgery, md proceeded with the biopsy.Surgeon attempted to remove the needle fragment in the ct scanner but was unsuccessful and felt fluoroscopy would be needed.Surgery successful in removing the needle with fluoroscopic guidance.A chest x-ray showed no pneumothorax or other complication.The patient recovered uneventfully, and a repeat chest x-ray 2 hours post removal showed no pneumothorax.Was discharged home in stable condition.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-sep-2023.H6: investigation summary: it was reported the needle snapped off at the hub.To aid in the investigation, a piece of a needle 1/2" long was received for evaluation by our quality team.A visual inspection was performed with a 30x microscope.There was no damage, defective grind or hooks observed.The bevels and etch were good.The other side of the needle shows it was bent inducing stress to the needle.There are no defect or imperfections in the area where the needle was broken or in any other section of the needle.This defect could occur if the needle was bent during the procedure.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17638573
• Report Number: 1911916-2023-00616
• Device Sequence Number: 18126818
• Product Code: FMI
• UDI-Device Identifier: 00382903051281
• UDI-Public: 00382903051281
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/11/2023

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: 305128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 14 YR
• Patient Sex: Female
• Patient Weight: 28 KG
• Patient Race: White