MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 21G 1IN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305165
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during medication preparation with 2 bd 21g 1in needle a hole was discovered at the base of the needle and leakage occurred.Medication sprayed into nurses glasses, there was no additional impact.The following information was provided by the initial reporter: customer reported that there is a hole at the base of the needle which leaks when preparing the medication.A nurse received some in her glasses, because there was a spurt that was projected when she gave the injection.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 25-jul-2023.H6: investigation summary it was reported there is a hole at the base of the needle which leaks.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed with a 10x magnifier lens.The sample has a molding short shot about 3/8" from the bottom of the needle hub.The sample was connected to a syringe with saline solution.There was leakage of saline solution through the molding short shot.No other defects or imperfections were observed.This defect could occur if the stripper bushing was worn.A device history record review was completed for provided material number 305165, lot 2228049.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The stripper bushing was replaced on (b)(6) 2023.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
It was reported that during medication preparation with 2 bd 21g 1in needle a hole was discovered at the base of the needle and leakage occurred.Medication sprayed into nurses glasses, there was no additional impact.The following information was provided by the initial reporter: customer reported that there is a hole at the base of the needle which leaks when preparing the medication.A nurse received some in her glasses, because there was a spurt that was projected when she gave the injection.

• Brand Name: BD 21G 1IN 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: 17312988
• Report Number: 1911916-2023-00478
• Device Sequence Number: 4057781
• Product Code: FMI
• UDI-Device Identifier: 00382903051656
• UDI-Public: (01)00382903051656
• 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,Followup
• Report Date (Section B): 07/26/2023

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: Health Professional
• Device Catalogue Number: 305165
• Device Lot Number: 2228049
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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
• Patient Sex: Unknown