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

Catalog Number	305274
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Fda notified?: the initial reporter also notified the fda via medwatch # mw5111968.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 tip of the plunger in the bd intregra¿ syringe with detachable needle pierced through the stopper during the injection, resulting in the patient not getting a full dose of medication.The following information was provided by the initial reporter: "while giving an injection with a bd integra syringe, the metal tip of the plunger broke through the plunger stopper.As a result, the patient received less than a full dose of medication.".
Event or Problem Description
It was reported that the tip of the plunger in the bd intregra¿ syringe with detachable needle pierced through the stopper during the injection, resulting in the patient not getting a full dose of medication.The following information was provided by the initial reporter: "while giving an injection with a bd integra syringe, the metal tip of the plunger broke through the plunger stopper.As a result, the patient received less than a full dose of medication.".
Additional Manufacturer Narrative
H6: investigation summary one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the cutter of the integra syringe had punctured through the stopper and the needle had not retracted.An unused physical sample is required for a more thorough evaluation.Potential root cause for the premature retraction defect is associated with the assembly process.These conditions are occurring below their expected frequency so no corrective action is required at this time.A device history record review was completed for provided lot number 1029961.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• Brand Name: BD INTREGRA¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15643232
• Report Number: 1213809-2022-00738
• Device Sequence Number: 6224624
• Product Code: MEG
• UDI-Device Identifier: 00382903052745
• UDI-Public: (01)00382903052745
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: Other
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 305274
• Device Lot Number: 1029961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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