MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE; PISTON SYRINGE

Model Number	305274
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 needle retraction failure occurred after use with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter, "a few minutes ago when giving estradiol, the needle would not retract.Just wanted to let you know.".
Additional Manufacturer Narrative
H.6 investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate the incident.No root cause can be determined as no samples were received.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.No corrective actions recommended since samples/photos were not received to confirm the product defect.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.H3 other text : see h.10.
Event or Problem Description
It was reported that needle retraction failure occurred after use with a bd integra¿ 3 ml syringe with detachable needle.The following information was provided by the initial reporter, "a few minutes ago when giving estradiol, the needle would not retract.Just wanted to let you know.".

• Brand Name: BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9594092
• Report Number: 1213809-2020-00005
• Device Sequence Number: 3341894
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (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): 01/31/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 7177705
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/31/2020
• 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