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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd precisionglide¿ needle broke from the hub into the patient during the anesthetic injection.As a result, the patient required an x-ray and excision.The following information was provided by the initial reporter: "needle broke off from the hub in the patient while they were using anesthetic." "the needle was left in the patient upon discharge from the office (b)(6) 2022.An x-ray was performed to confirm the foreign body, followed by an excision.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 30-nov-2022 h6: investigation summary it was reported a needle broken inside a patient.To aid in the investigation, ninety-nine samples in sealed packaging blisters were received for evaluation by our quality team.Each sample was visually inspected.First, with a 10x magnifier lens, and then with a 30x microscope.No damages, marks or any other condition that could induce needle breakage was observed.Two reports were also provided.One stated the patient had a needle in the body and the other after the removal of it.A device history record review was completed for provided material number 305128, lot number 2020908.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed, and a probable root cause could not be offered.
Event or Problem Description
It was reported that the bd precisionglide¿ needle broke from the hub into the patient during the anesthetic injection.As a result, the patient required an x-ray and excision.The following information was provided by the initial reporter: "needle broke off from the hub in the patient while they were using anesthetic." "the needle was left in the patient upon discharge from the office (b)(6)2022.An x-ray was performed to confirm the foreign body, followed by an excision.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859270
• Report Number: 1911916-2022-00676
• Device Sequence Number: 5716894
• Product Code: FMI
• UDI-Device Identifier: 00382903051281
• UDI-Public: (01)00382903051281
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/26/2022

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 Catalogue Number: 305128
• Device Lot Number: 2020908
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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