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

Catalog Number	305272
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using 2 bd integra¿ 3 ml syringes they detached during use.Consumer said he is still concerned about the needle.He did not seek medical attention, no pain or discomfort.Consumer informed of demographics stated not in any pain.Never completed the xrays.Informed this caller of the function of this syringe and the retracting needles.Caller now feels the needle retracted in the way it should have now knowing this information.Two needles detached from syringe, got stuck in patient's "rear end" - patient is going to urgent care for removal.
Event or Problem Description
It was reported while using 2 bd integra¿ 3 ml syringes they detached during use.The following information was provided by the initial reporter: consumer said he is still concerned about the needle.He did not seek medical attention, no pain or discomfort.Consumer informed of demographics stated not in any pain.Never completed the xrays.Informed this caller of the function of this syringe and the retracting needles.Caller now feels the needle retracted in the way it should have now knowing this information.Two needles detached from syringe, got stuck in patient's "rear end" - patient is going to urgent care for removal.
Additional Manufacturer Narrative
H6: investigation summary: a device history review was conducted for lot number 2018459.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.As a sample was not returned a thorough sample investigation could not be completed.This product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• 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 ; 8015296192
• MDR Report Key: 15191012
• Report Number: 1213809-2022-00466
• Device Sequence Number: 20219367
• Product Code: MEG
• UDI-Device Identifier: 00382903052721
• UDI-Public: 00382903052721
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: Lay User/Patient
• Device Catalogue Number: 305272
• Device Lot Number: 2018459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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
• Patient Sex: Unknown