MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305122
Medical Device Problem Codes	Contamination (1120); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305122.Batch number#: 3145665.It was reported by customer that they opened a box of 25g x 5/8¿ bd precisionglide needle and there was an unpackaged needle in the new box, the cap was still on.Needle was dirty.Verbatim#: good morning, i had a staff member open a box of 25g x 5/8¿ bd precisionglide needle and there was an unpackaged needle in the new box, the cap was still on.Needle was dirty.Lot-3145665, exp-6/30/28.Just wanted to make you aware.
Additional Manufacturer Narrative
(b)(4): 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.It was reported an unpackaged needle was in the new box with the cap on and a dirty needle.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 human hand holding a needle assembly with the plastic shield.The plastic shield has dark colored specks.From the photo it is not possible to confirm if the specks are loose or are embedded degraded resin.For the loose part, the possible root cause is unknown as the packaging process is automated and handles only packaged parts; units without packaging would not go through the processes.For the foreign matter defect, the actual physical sample would be required to determine the root cause.A device history record review was completed for provided material number 305122, lot 3145665.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.
Event or Problem Description
No additional information received.Material#: 305122, batch number#: 3145665.It was reported by customer that they opened a box of 25g x 5/8¿ bd precisionglide needle and there was an unpackaged needle in the new box, the cap was still on.Needle was dirty.Verbatim#: good morning, i had a staff member open a box of 25g x 5/8¿ bd precisionglide needle and there was an unpackaged needle in the new box, the cap was still on.Needle was dirty.Lot-3145665.Exp-6/30/28.Just wanted to make you aware.Response: on 3/15/24.

• Brand Name: NEEDLE 25X5/8 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: 18977706
• Report Number: 1911916-2024-00215
• Device Sequence Number: 6299396
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: 305122
• Device Lot Number: 3145665
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 03/28/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown