MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number	305271
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the metal component in the bd integra¿ syringe with detachable needle broke through the stopper during the injection, causing medication to spill out.The following information was provided by the initial reporter: "customer reports they inserted syringe needle into hip, pushed down for injection the medication spilled outward.Metal component went through stopper which broke the seal and was not able to provide a shot.".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 metal component in the bd integra¿ syringe with detachable needle broke through the stopper during the injection, causing medication to spill out.The following information was provided by the initial reporter: "customer reports they inserted syringe needle into hip, pushed down for injection the medication spilled outward.Metal component went through stopper which broke the seal and was not able to provide a shot.".
Additional Manufacturer Narrative
H6: investigation summary one photo was provided to our quality team for investigation.The photo shows a loose syringe next to the package showing most of the pre-printed product information.The cutter has cut through the stopper and the needle is still inside the shield without being retracted.The condition observed is non-conforming per product specification.An unused physical sample from same lot is required for a more thorough evaluation.Potential root cause for the premature retraction and leakage defects are associated with the assembly process.These defects are occurring below an expected rate so no corrective actions will be made at this time.A device history record review was completed for provided lot number 1081333.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17507462
• Report Number: 1213809-2023-00846
• Device Sequence Number: 15049992
• Product Code: MEG
• UDI-Device Identifier: 00382903052714
• UDI-Public: 00382903052714
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/25/2023

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: Other
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 305271
• Device Lot Number: 1081333
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 09/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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