MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE 3ML W/NDL 22X1-1/2 RB; ANTISTICK SYRINGE

Model Number	305272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.¿ device manufacture date: unknown.
Event or Problem Description
It was reported that the bd integra¿ syringe 3ml w/ndl 22x1-1/2 rb broke during use.The following information was completed by the initial reporter: customer called in regards of the 3ml syringe and stated that it broke during use.No harm to customer, however went and got an x-ray done to make sure needle was not stuck inside.
Additional Manufacturer Narrative
H6: investigation summary: it was reported that needle is broke during use.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A device history review could not be completed as no batch number was provided.
Event or Problem Description
It was reported that the bd integra¿ syringe 3ml w/ndl 22x1-1/2 rb broke during use.The following information was completed by the initial reporter: customer called in regards of the 3ml syringe and stated that it broke during use.No harm to customer, however went and got an x-ray done to make sure needle was not stuck inside.

• Brand Name: BD INTEGRA¿ SYRINGE 3ML W/NDL 22X1-1/2 RB
• Common Device Name: ANTISTICK 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: 14809889
• Report Number: 1213809-2022-00353
• Device Sequence Number: 11931357
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• 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: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: Lay User/Patient
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: UNKNOWN
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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