MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
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 #: 305195 batch #: 4031647 it was reported by the customer that there are black flecks along inside of the needle cap - unopened packaging - can see black fleck along the inside of cap.Verbatim: rcc received a complaint via phone.Pir attached.There are black flecks along inside of the needle cap - unopened packaging - can see black fleck along the inside of cap no imppact - needles used in compounding environment and no direct patient contact.Product code: 305195.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there are black flecks along the inside of the needle cap.To aid in the investigation, forty-nine samples in sealed packaging blisters were received for evaluation by our quality team.There were nine strips of five sealed packaging blisters and one strip of four sealed packaging blisters.Ten packaging blisters were marked with an 'x.' a visual inspection was performed.First, with 10x magnification and then with 30x magnification.No defects or imperfections were observed.A device history record review was completed for provided material number 305195, lot 4031647.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 could not be confirmed.
Event or Problem Description
No additional information received.Material #: 305195.Batch #: 4031647.It was reported by the customer that there are black flecks along inside of the needle cap - unopened packaging - can see black fleck along the inside of cap.Verbatim: rcc received a complaint via phone.There are black flecks along inside of the needle cap - unopened packaging - can see black fleck along the inside of cap.No impact - needles used in compounding environment and no direct patient contact.Product code: 305195.

• Brand Name: NEEDLE 18X1 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: 19883694
• Report Number: 1911916-2024-00561
• Device Sequence Number: 4144664
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/20/2024

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: 305195
• Device Lot Number: 4031647
• 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: 07/30/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown