MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 21X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305165 lot # 2056673 it was reported by customer that they had an issue with a 21 g bd precisionglide needle.While using this needle and a 3ml luer lock bd syringe to transfer contents of vial 1 to vial 2 in a pharmaceutical prep they noticed a small spray of liquid coming out from the hub of the needle.Verbatim: rcc received a complaint via email.Email(s) attached.Today we had an issue with a 21 g bd precisionglide needle.While using this needle and a 3ml luer lock bd syringe to transfer contents of vial 1 to vial 2 in a pharmaceutical prep we noticed a small spray of liquid coming out from the hub of the needle.We repeated the motion of injecting liquid into a vial and saw the spray again.Product: bd precision glide needle 21g x 1 (0.8mm x 25 mm) ref (b)(4) lot 2056673.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
No additional information received material # 305165 lot # 2056673 it was reported by customer that they had an issue with a 21 g bd precisionglide needle.While using this needle and a 3ml luer lock bd syringe to transfer contents of vial 1 to vial 2 in a pharmaceutical prep they noticed a small spray of liquid coming out from the hub of the needle.Verbatim: rcc received a complaint via email.Email(s) attached.Today we had an issue with a 21 g bd precisionglide needle.While using this needle and a 3ml luer lock bd syringe to transfer contents of vial 1 to vial 2 in a pharmaceutical prep we noticed a small spray of liquid coming out from the hub of the needle.We repeated the motion of injecting liquid into a vial and saw the spray again.Product: bd precision glide needle 21g x 1 (0.8mm x 25 mm) ref (b)(4) lot 2056673.
Additional Manufacturer Narrative
Pr (b)(4)follow up for device evaluation it was reported a small spray of liquid came out from the hub of the needle.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.There is a molding short shot about 3/8" from the bottom of the needle hub.The sample was assembled to a syringe with saline solution.There is leakage of the solution through the molding short shot.No other defects or imperfections were observed.After analysis of the sample, and the molding tool, it was determined that wear of the stripper bushing contributed to the symptom reported.The stripper bushing was replaced (b)(6) 2023.A device history record review was completed for provided material number 305165, lot 2056673.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.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 is confirmed.

• Brand Name: NEEDLE 21X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19249669
• Report Number: 1911916-2024-00321
• Device Sequence Number: 6397058
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: 2056673
• 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: 05/02/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown