MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB; PISTON SYRINGE

Catalog Number	305272
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb needle collapsed.This occurred on 3 occasions.The following information was provided by the initial reporter: material no: 305272, batch no: unknown.It was reported that the needle collapsed inside the syringe.Verbatim: consumer reported while injecting testosterone with one syringe the needle "collapsed" inside the syringe.Consumer reported while placing air into vial of testosterone with 2 other syringes the needle collapsed into the syringe.Informed consumer of the function of this retracting syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-06-02.H6: investigation summary: one loose 3ml integra syringe with needle (p/n 305272) was received with an opened blisterpak.The batch number and expiration date were not legible, it is unclear if this occurred from product handling or the manufacturing process.The graphics on the top web of the package were confirmed to be in production between august 2009 and december 2013.The syringe had been activated but the needle was still present inside the shield and there was no indication that the steel cutter had punctured the seal on the needle to initiate needle retraction.Please note this product was expired since at least december 2018 as indicated by the age of the graphics revision on the package and bd does not make claims about the performance or efficacy of expired products.H3 other text : see h10.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb needle collapsed.This occurred on 3 occasions.The following information was provided by the initial reporter: material no: 305272 batch no: unknown.It was reported that the needle collapsed inside the syringe.Verbatim: consumer reported while injecting testosterone with one syringe the needle "collapsed" inside the syringe.Consumer reported while placing air into vial of testosterone with 2 other syringes the needle collapsed into the syringe.Informed consumer of the function of this retracting syringe.
Additional Manufacturer Narrative
H6: investigation summary.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this 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.
Event or Problem Description
It was reported that syringe integra 3ml w/ndl 22x1-1/2 rb needle collapsed.This occurred on 3 occasions.The following information was provided by the initial reporter: material no: 305272 batch no: unknown.It was reported that the needle collapsed inside the syringe.Verbatim: consumer reported while injecting testosterone with one syringe the needle "collapsed" inside the syringe.Consumer reported while placing air into vial of testosterone with 2 other syringes the needle collapsed into the syringe.Informed consumer of the function of this retracting syringe.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 22X1-1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11680431
• Report Number: 1213809-2021-00240
• Device Sequence Number: 4157687
• Product Code: MEG
• UDI-Device Identifier: 00382903052721
• UDI-Public: 00382903052721
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2021

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: Other
• Device Catalogue Number: 305272
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 05/07/2021; 06/11/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/24/2021; 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1