MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material #: 305197 batch#: 3334871.It was reported by customer that black specks found in bd 16 gauge 1" compounding needles multiple needles of lot 3334871 found with tiny black specks inside of luer lock or cap of packaged needles.Potential sterility/contamination issue during compounding of sterile iv products, which may have already occurred.All needles with specific lot/expiration of 3334871/[redacted date] were segregated and isolated from main supply.Awaiting investigation." manufacturer response for 16 gauge 1" compounding needles, 16 gauge 1" compounding needles (per site reporter) mfg letter of investigation attached, no findings, lot complied with qc.Complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached.Item# 305197 black specks found in bd 16 gauge 1" compounding needles multiple needles of lot 3334871 found with tiny black specks inside of luer lock or cap of packaged needles.Potential sterility/contamination issue during compounding of sterile iv products, which may have already occurred.All needles with specific lot/expiration of 3334871/[redacted date] were segregated and isolated from main supply.Awaiting investigation." manufacturer response for 16 gauge 1" compounding needles, 16 gauge 1" compounding needles (per site reporter) mfg letter of investigation attached, no findings, lot complied with qc.
Event or Problem Description
No additional information received: material #: 305197, batch#: 3334871.It was reported by customer that black specks found in bd 16 gauge 1" compounding needles multiple needles of lot 3334871 found with tiny black specks inside of luer lock or cap of packaged needles.Potential sterility/contamination issue during compounding of sterile iv products, which may have already occurred.All needles with specific lot/expiration of 3334871/[redacted date] were segregated and isolated from main supply.Awaiting investigation." manufacturer response for 16 gauge 1" compounding needles, 16 gauge 1" compounding needles (per site reporter) mfg letter of investigation attached, no findings, lot complied with qc.Verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Item# 305197.Black specks found in.Bd 16 gauge 1" compounding needles.Multiple needles of lot 3334871 found with tiny black specks inside of luer lock or cap of packaged needles.Potential sterility/contamination issue during compounding of sterile iv products, which may have already occurred.All needles with specific lot/expiration of 3334871/[redacted date] were segregated and isolated from main supply.Awaiting investigation." manufacturer response for 16 gauge 1" compounding needles, 16 gauge 1" compounding needles (per site reporter) mfg letter of investigation attached, no findings, lot complied with qc.
Additional Manufacturer Narrative
(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 305197 and lot number 3334871.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

• Brand Name: NEEDLE 16X1 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: 20084839
• Report Number: 1911916-2024-00632
• Device Sequence Number: 12715408
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978(11)231130(17)281231(10)3334871
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 09/11/2024

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: 305197
• Device Lot Number: 3334871
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown