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

Model Number	305283
Medical Device Problem Codes	Partial Blockage (1065); Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe integra 3ml ll had a difficult to move plunger and had a needle retraction failure.The following information was provided by the initial reporter: "the syringe pushed through so that the remaining 0.2ml could not be infused while the needle was still in the patient's buttock.In addition, the needle should shoot back into the syringe for safety reasons (after pushing through), but this did not happen.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/11/2022.H.6.Investigation: two photos and one sample of a 3ml integra syringe (p/n 305283) were received and evaluated.It was observed that the plunger rod was pressed into the syringe which punctured the stopper, and the cutter was visible, but the needle did not retract into the syringe.The needle was still visible at the end of the syringe.Potential root cause for the premature retraction and retraction failure defects are associated with the assembly process.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.H3 other text : see h.10.
Event or Problem Description
It was reported that bd syringe integra 3ml ll had a difficult to move plunger and had a needle retraction failure.The following information was provided by the initial reporter: " the syringe pushed through so that the remaining 0.2ml could not be infused while the needle was still in the patient's buttock.In addition, the needle should shoot back into the syringe for safety reasons (after pushing through), but this did not happen.".

• Brand Name: BD SYRINGE INTEGRA 3ML LL
• 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: 13121262
• Report Number: 1213809-2021-00828
• Device Sequence Number: 11925737
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 06/30/2023
• Device Model Number: 305283
• Device Catalogue Number: 305283
• Device Lot Number: 8184681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2018
• 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