MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE WITH DETACHABLE 21 G X 1 1/2 IN. NEEDLE; PISTON SYRINGE

Model Number	305274
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports, and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore, a root cause could not be determined.
Event or Problem Description
It was reported that bd integra¿ 3 ml syringe with detachable 21 g x 1 1/2 in.Needle had retraction failures.This was discovered during use.The following information was provided by the initial reporter: im injection was administered, and needle did not retract on release.Extra force had to be given to ensure needle retracted.

• Brand Name: BD INTEGRA 3 ML SYRINGE WITH DETACHABLE 21 G X 1 1/2 IN. NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10614415
• Report Number: 1213809-2020-00683
• Device Sequence Number: 16795396
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 01/31/2025
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 0055251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other