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

Catalog Number	305269
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd integra¿ 3 ml retracting safety syringe the drug spilled out from the tip.Report 1 of 2.The following was received by the initial reporter: verbatim: presented to clinic on (b)(6) 2023 for c4d1 of 3,000mcg/kg dose.Dose was split into 2 separate syringes for a total volume of 2.1ml.The 1st injection was administered without any incident.The 2nd injection, a syringe malfunction occurred and the drug spilled out from the tip of the syringe.The nurse believe there was an issue with the syringe needle cap, unsure if the needle prematurely retracted.The patient did not experienced any harm.
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-jul-2023.H6: investigation summary three samples were provided to our quality team for investigation.All samples were tested for leakage.None of the samples showed any signs of the reported defect.Since the reported defects were not confirmed a manufacturing root cause could not be determined.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.
Event or Problem Description
It was reported that while using the bd integra¿ 3 ml retracting safety syringe the drug spilled out from the tip.Report 1 of 2.The following was received by the intiial reporter: verbatim: presented to clinic on 21jun23 for c4d1 of 3,000mcg/kg dose.Dose was split into 2 separate syringes for a total volume of 2.1ml.The 1st injection was administered without any incident.The 2nd injection, a syringe malfunction occurred and the drug spilled out from the tip of the syringe.The nurse believe there was an issue with the syringe needle cap, unsure if the needle prematurely retracted.The patient did not experienced any harm.

• Brand Name: BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17410259
• Report Number: 1213809-2023-00771
• Device Sequence Number: 7090169
• Product Code: FMF
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: 09/30/2024
• Device Catalogue Number: 305269
• Device Lot Number: 9268943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2019
• 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