MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML W/NDL; ANTISTICK SYRINGE

Model Number	305272
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 at least 3 bd syringe integra 3ml w/ndl experienced device damage while still considered operable.The following information was provided by the initial reporter: the metal pin pushing the rubber plunger has broken through the plunger at least 3 times while using this syringe.It happens when i gave myself a testosterone injection and when my wife gave me an injection.I told the pharmacy and they said push the syringe slower.That has not helped.I worried may inject a foreign material in my made with the syringe breaking and also concerned that i'm not getting the correct dosage.
Event or Problem Description
It was reported that at least 3 bd syringe integra 3ml w/ndl experienced device damage while still considered operable.The following information was provided by the initial reporter: the metal pin pushing the rubber plunger has broken through the plunger at least 3 times while using this syringe.It happens when i gave myself a testosterone injection and when my wife gave me an injection.I told the pharmacy and they said push the syringe slower.That has not helped.I worried may inject a foreign material in my made with the syringe breaking and also concerned that i'm not getting the correct dosage.
Additional Manufacturer Narrative
H6: investigation summary it was reported the metal pin pushed through the plunger.To aid in the investigation, two photos of a 3ml integra syringe was received for evaluation by our quality team.One photo shows the top web graphics side of a packaging blister.However, the small print including the batch and expiration date are not legible due to blurriness.The second photo shows the sample packaging blister, once again with illegible small print.The second image also shows the components of an integra syringe with the needle hub inside a shield, spring, cannula and the syringe with the cutter exposed through the stopper.The reported defect could not be confirmed from the photos provided.Any unused physical samples are required for testing to be performed by a trained bd associate to determine a more thorough evaluation for premature retraction and potential root cause determination.A device history record review was completed for provided material number 305272, lot number 1020489.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1020489 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.To date, there have been no other similar events reported for this lot.

• Brand Name: BD SYRINGE INTEGRA 3ML W/NDL
• Common Device Name: ANTISTICK 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: 15801061
• Report Number: 1213809-2022-00993
• Device Sequence Number: 4754749
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: Lay User/Patient
• Device Expiration Date: 01/31/2026
• Device Model Number: 305272
• Device Catalogue Number: 305272
• Device Lot Number: 1020489
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 01/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2021
• 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