MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE SFTYGLD 25X1 RB MCK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	306616
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd needle sftygld 25x1 rb mck was broken.The following information was provided by the initial reporter: material # 306616.Batch # unknown.Verbatim: account gave an hpv shot to a young patient over a year ago.The patient recently came back in and it was discovered a needle is in the patients arm and has been working its way down through the muscle.The account does not know if its the needle from the hpv shot or when the incident occurred, but the account would like to speak to someone at bd regarding the event.Customer response on 13-may-2025.1.Can you please provide an exact date of event? (b)(6) 2024.2.Can you please provide the material and lot number associated with reported issue? prevent sg safety hypodermic needle glide non-pyrogenic sterile 25g x 1inch.Mfr: 192-n251s.I cannot confirm the lot number due time that has past from the event.The current lot number we have in stock in clinic is 0141231.3.Please describe any additional, unplanned medical or surgical intervention (e.G., additional/alternative medications, imaging, etc.) required to avoid patient harm.Needle was discovered via an xray recently due to a separate, unrelated injury.Patient has a follow up on (b)(6) 2025 to discuss removal of needle from arm.
Additional Manufacturer Narrative
D.3.Franklin lakes has been listed as the manufacturer.G.1.Franklin lakes has been listed as the manufacturer.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr/correction - needle broken.Correction: following submission of initial mdr, lot number was not reported.Correct lot number is 0141231.Evaluation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Batch 0141231 is considered in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SFTYGLD 25X1 RB MCK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22074688
• Report Number: 2243072-2025-00671
• Device Sequence Number: 8702763
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598(10)0141231
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 306616
• Device Lot Number: 0141231
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown