MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305269
Medical Device Problem Codes	Complete Blockage (1094); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd integra¿ syringe with detachable needle the needle was clogged.The following was received by the initial reporter.The issue was solution did not inject and back fired externally.
Additional Manufacturer Narrative
E.1.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample was received by bd for evaluation.A quality engineer was able to review the sample of a 3ml syringe from lot #1278258 regarding item #(b)(4).The customer reported that "solution did not inject and back fired externally".The syringe was received in an opened package with all applicable product information on the top web.The syringe had the cannula and spring located inside the barrel with the stopper having been cut.It is possible that the syringe activated prematurely resulting in the cutting of the stopper and leakage of medication.A device history record review was completed for provided batch number 1278258.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.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 INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17786398
• Report Number: 1213809-2023-01048
• Device Sequence Number: 6884111
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 305269
• Device Lot Number: 1278258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown