MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ RETRACTING SAFETY SYRINGE 25 G X 5/8 IN. WITH 3ML SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305269
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd integra¿ retracting safety syringe 25 g x 5/8 in.With 3ml syringe the needle did not retract properly.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the syringe needle and the plunger went into their arm.As this had never happened to them before they were concerned and went to the emergency room for x-rays of their arm to see if the needle was stuck inside.The customer indicated that the x-rays were negative and did not show any parts of the medical device lodged in their arm.No additional pain or swelling has been noticed by the customer since the injection.
Event or Problem Description
It was reported while using bd integra¿ retracting safety syringe 25 g x 5/8 in.With 3ml syringe the needle did not retract properly.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that the syringe needle and the plunger went into their arm.As this had never happened to them before they were concerned and went to the emergency room for x-rays of their arm to see if the needle was stuck inside.The customer indicated that the x-rays were negative and did not show any parts of the medical device lodged in their arm.No additional pain or swelling has been noticed by the customer since the injection.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received by our quality team for evaluation.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety when adequate pressure is applied to the inner plunger rod.A device history review was conducted for lot number 2271481 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.H3 other text : see h10.

• Brand Name: BD INTEGRA¿ RETRACTING SAFETY SYRINGE 25 G X 5/8 IN. WITH 3ML SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17114536
• Report Number: 1213809-2023-00640
• Device Sequence Number: 15254192
• Product Code: FMI
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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: Other
• Device Model Number: 305269
• Device Catalogue Number: 305269
• Device Lot Number: 2271481
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 06/12/2023
• Supplement Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown