MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE

Model Number	305271
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 23x1 rb experienced a collapse of the plunger rod.The following information was provided by the initial reporter: syringe broke in pieces; stated, a "spring" popped out of the barrel.
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 0325703.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.
Event or Problem Description
It was reported that the bd syringe integra 3ml w/ndl 23x1 rb experienced a collapse of the plunger rod.The following information was provided by the initial reporter: syringe broke in pieces; stated, a "spring" popped out of the barrel.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• 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: 15236357
• Report Number: 1213809-2022-00500
• Device Sequence Number: 6446778
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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 Expiration Date: 10/31/2025
• Device Model Number: 305271
• Device Catalogue Number: 305271
• Device Lot Number: 0325703
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 08/16/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2020
• 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