MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB; SYRINGE, ANTISTICK

Catalog Number	305271
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)
Health Effect - Clinical Codes	Unintended Radiation Exposure (4565); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 23x1 rb retracted as intended and patient reported he could not find needle after injection.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Contact name: (b)(6).Contact number: (b)(6).Contact email (if available): (b)(6).Item(s): 305271.Lot(s):1081332.Date incident occurred: (b)(6) 2025.Was the patient impacted? yes could not find needle after injection so went to the emergency room found out that it is a retractable needle.If yes, describe: print too small to see.Is a sample available? yes.Customer responded on (b)(6) my address is: i was in the urgent care for 4 hours and was x-rayed.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Additional information provided on 01-may-2025.Patient alleges that the subject needle would not retract unless significant pressure was put on it.
Additional Manufacturer Narrative
(b)(4) follow up report for additional information / correction.Adverse type should be both an adverse event and product problem.Correct event/product problem should be safety mechanism failure.Annex a code should be a1501 - activation problem.Annex e code should be e2119 - unintended radiation exposure.Annex f code should be f12 - serious injury/ illness/ impairment.
Additional Manufacturer Narrative
(b)(6) - supplemental mdr - safety mechanism failure.Two photos of a 3 ml integra syringe (material 305271, batch 1081332) were received and reviewed.The first image shows a fully assembled loose syringe with the cap detached, placed next to a sealed package viewed from the top web slip side, displaying all required labeling.The second image appears to show the same loose syringe alongside a fully assembled syringe within a sealed package, viewed from the transparent bottom web.No defects were observed in either image.Since no samples displaying the reported condition were received, a potential root cause could not be determined, and corrective actions are not necessary.Furthermore, a device history record review was completed for provided lot number 1081332.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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 SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• 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: 21845524
• Report Number: 1213809-2025-00276
• Device Sequence Number: 18512124
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715(11)210322(17)260331(10)1081332
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2025

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: Lay User/Patient
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 305271
• Device Lot Number: 1081332
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 05/01/2025; 06/03/2025
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 05/05/2025; 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2021
• 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