MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 5/8 IN. SINGLE USE, STERILE, 25 G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305122
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Chemical Exposure (2570)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s birthday was not provided, (b)(6) 1949 was used based on age of patient.Investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.
Event or Problem Description
It was reported while using bd® needle 5/8 in.Single use, sterile, 25 g there was a damaged needle hub and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: to prepare for a nuclear medicine scan, nurse attempted to inject 74-year-old patient with radioactive material.Due to a crack in the needle hub, a small amount of material leaked through the crack and touched the patient¿s skin before dripping onto the arm of the chair.The spill was contained and cleaned according to hazardous spill protocol.The same volume of material was drawn up, and, though a second venipuncture, injected into the patient.

• Brand Name: BD® NEEDLE 5/8 IN. SINGLE USE, STERILE, 25 G
• 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: 16916942
• Report Number: 1911916-2023-00300
• Device Sequence Number: 17875324
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• 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): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 305122
• Device Catalogue Number: 305122
• Device Lot Number: UNKNOWN
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 74 YR
• Patient Sex: Unknown