MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB; SYRINGE, ANTISTICK

Catalog Number	305269
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
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
Material #:305269 batch#:3314055 it was reported that the bd syringe integra 3ml ll w/ndl 25x5/8 rb had a needle retraction failure.The following information was provided by the initial reporter: "the safety of the bd integra did not retract." additional information provided: 1.Please provide the date of event.6/5/2024 2.Please provide the picture sample if available? photo attached 3.Any physical sample available for investigation? only photo available 4.Did the event directly, or indirectly involve a patient or user? syringe did not retract after use with a patient.No patient injury 5.Please confirm the number of occurrences.One.
Additional Manufacturer Narrative
One photo of a 3ml integra syringe package (p/n ¿ 305269) batch 3314055 was received and evaluated.The image shows one top web slip with all applicable product information on the packaging.There is no syringe in the photo, and the condition reported cannot be confirmed from the photo received.The condition observed is acceptable per product specification.The reported defect was not identified in the photo received.A physical sample is required for a more thorough evaluation and potential root cause determination.Therefore, no corrective action is required at this time.A device history record review was completed for provided lot number 3314055 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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 LL W/NDL 25X5/8 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: 19570925
• Report Number: 1213809-2024-00394
• Device Sequence Number: 17183565
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692(11)231110(17)281031(10)3314055
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• 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): 12/19/2024

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: 305269
• Device Lot Number: 3314055
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown