MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 21X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305167
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305167.Batch # 2228395.It was reported by customer that the pin hole in hub of bd precision glide needle allowing for leakage of medication during sterile compounding.Verbatim: rcc received a complaint via email.Email(s) attached.Pin hole in hub of bd precisionglide needle allowing for leakage of medication during sterile compounding.Occurred on three separate instances with needles from the same lot.Reference reports: mw5158145 and mw5158147.
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.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there was a pin hole in hub of the needle.To aid in the investigation, one sample in an opened packaging blister was received for evaluation by our quality team.A visual inspection was performed.The needle hub has a molding short shot approximately 3/16" from the bottom of the needle hub.No other defects or imperfections were observed.Previous investigations have confirmed a short shot from the molding process.After analysis of the molding tool, it was determined possible wear of the stripper bushing could contributed to the defect.The stripper bushing was replaced february 2023.A device history record review was completed for provided material number 305167, lot 2228395.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.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
Additional information received.No adverse event or serious injury reported.Material # 305167; batch # 2228395.It was reported by customer that the pin hole in hub of bd precision glide needle allowing for leakage of medication during sterile compounding.Verbatim: rcc received a complaint via email.Pin hole in hub of bd precisionglide needle allowing for leakage of medication during sterile compounding.Occurred on three separate instances with needles from the same lot.Reference reports: mw5158145 and mw5158147.

• Brand Name: NEEDLE 21X1-1/2 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: 20128452
• Report Number: 1911916-2024-00638
• Device Sequence Number: 11579601
• Product Code: FMI
• UDI-Device Identifier: 30382903051671
• UDI-Public: (01)30382903051671(11)220816(17)271130(10)2228395
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 305167
• Device Lot Number: 2228395
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown