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

Catalog Number	305272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a bd syringe integra 3ml w/ndl 22x1-1/2 rb an adverse event without product malfunction led to the user visiting the hospital.There was no report of patient impact.The following information was provided by the initial reporter: needle retracted at the end of injection and thought it broke in site.Caller went to urgent care they informed caller to visit local emergency room.The emergency room completed ultra sound and xray.Did not locate the needle.Caller took the syringe apart as i was speaking and found the needle and was satisfied.
Event or Problem Description
It was reported while using a bd syringe integra 3ml w/ndl 22x1-1/2 rb an adverse event without product malfunction led to the user visiting the hospital.The following information was provided by the initial reporter: needle retracted at the end of injection and thought it broke in site.Caller went to ugent care they informed caller to visit local er.The er completed ultra sound and xray.Did not locate the needle.Caller took the syringe apart as i was speaking and found the needle and was satisfied.
Additional Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 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: 15470260
• Report Number: 1213809-2022-00622
• Device Sequence Number: 19914172
• Product Code: FMF
• UDI-Device Identifier: 00382903052721
• UDI-Public: 00382903052721
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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?: No
• Operator of Device: Other
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 305272
• Device Lot Number: 1020489
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown