MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 25X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305125
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation: it was reported that customer was receiving an injection and the needle snapped off the hub, and stayed in his body, another needle used 2 weeks ago bent during an injection.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows a needle assembly in a packaging blister.The other photo shows a packaging blister top web.As a sample was unavailable for return, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 305125, lot number 0274528.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported needle 25x1 rb broke off into the patient's body during injection.The patient went to the er, but they were unable to remove the needle.A future surgery was scheduled to remove the needle.The following information was provided by the initial reporter: "he said he was receiving an injection, and the needle snapped off the hub, and stayed in his body." "customer explained that the podiatrist he sees was "dry needling" with the hub against the skin when the needle broke - customer went to the er to have needle removed - er did not remove needle - customer has another appt for surgery to remove needle with another surgeon".

• Brand Name: NEEDLE 25X1 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12236644
• Report Number: 1911916-2021-00733
• Device Sequence Number: 5403002
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: 30382903051251
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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 Expiration Date: 09/30/2025
• Device Model Number: 305125
• Device Catalogue Number: 305125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention