MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA SYRINGE; PISTON SYRINGE

Model Number	305283
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2021
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, therefore a root cause could not be determined.Furthermore, 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.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.
Event or Problem Description
It was reported that the bd integra¿ syringe needle failed to retract and had to be removed by manually releasing the spring.The following information was provided by the initial reporter, translated from (b)(6) to english: "when administering an im injection, the nurse noticed at the start of the injection that the plunger showed resistance.Extra pressure was needed to administer the liquid.After the injection, the system blocked to allow the needle to retract safely.The nurse had to remove the needle herself, releasing the spring and noticing that some fluid remained in the syringe.".

• Brand Name: BD INTEGRA SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11388483
• Report Number: 1213809-2021-00111
• Device Sequence Number: 3247405
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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: 03/31/2023
• Device Model Number: 305283
• Device Catalogue Number: 305283
• Device Lot Number: 8092763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1