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

Catalog Number	305165
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr 9926102: 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
Material: 305165 batch#: 3334855 it was reported by the customer that one of our pharmacists identified a needle with several dark spots on it.It is still sealed so i can not tell exactly where it is in the packaging.Verbatim: one of our pharmacists identified a needle with several dark spots on it.It is still sealed so i can not tell exactly where it is in the packaging.
Additional Manufacturer Narrative
(b)(4) follow up it was reported there was a needle with several dark spots on it.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a packaging blister with a needle assembly in it.From the photo, it appears the plastic shield has a black speck in it.No other information could be obtained from the photo.A device history record review was completed for provided material number 305165, lot 3334855.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 photo sample analysis the symptom reported by the customer is confirmed, but without the actual physical sample analysis a probable root cause could not be offered.
Event or Problem Description
No additional information received material: 305165 batch#: 3334855 it was reported by the customer that one of our pharmacists identified a needle with several dark spots on it.It is still sealed so i can not tell exactly where it is in the packaging.Verbatim: one of our pharmacists identified a needle with several dark spots on it.It is still sealed so i can not tell exactly where it is in the packaging.

• 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: 19004606
• Report Number: 1911916-2024-00222
• Device Sequence Number: 13107361
• Product Code: FMI
• UDI-Device Identifier: 30382903051657
• UDI-Public: (01)30382903051657
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/30/2024

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: 3334855
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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