MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE; SYRINGE, ANTISTICK

Model Number	305274
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).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 that the 3 ml bd integra¿ retracting safety syringe safety mechanism did not activate.  the following information was provided by the reporter.During an intervention with an agitated patient, when it was time to activate the safety mechanism, the needle was twisted and the device did not secure the needle.The patient was very agitated and struggling, which explains why the needle was deformed, but it is precisely for these situations that we want safe equipment.
Event or Problem Description
It was reported that the 3 ml bd integra¿ retracting safety syringe safety mechanism did not activate.  the following information was provided by the reporter.During an intervention with an agitated patient, when it was time to activate the safety mechanism, the needle was twisted and the device did not secure the needle.The patient was very agitated and struggling, which explains why the needle was deformed, but it is precisely for these situations that we want safe equipment.
Additional Manufacturer Narrative
H.6.Investigation: four photos were provided to our quality team for investigation.It was observed that the needle did not retract all the way into the syringe barrel due to the bent condition of the needle because of the attempted injection.Potential root cause for the needle bent/retraction could not be related to manufacturing process.Since the reported condition is related to customer use, corrective actions are not necessary.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.

• Brand Name: 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14528212
• Report Number: 1213809-2022-00304
• Device Sequence Number: 5798691
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2022

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: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 1020490
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 05/28/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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