MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB; SYRINGE, ANTISTICK

Catalog Number	305269
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material#: 305269, batch number#: 3234572.It was reported that the bd syringe integra 3ml ll w/ndl 25x5/8 rb had a needle retraction failure (integra).The following information was provided by the initial reporter: the ed reported an issue they had with a 3ml integra syringe which i¿m making you aware of.It¿s difficult to say exactly how this happened and whether it was user error, but am reporting it to you in case there are any further incidents here.She said ¿the rn attempted to administer an im medication.Upon administration, medication noted to leak out of syringe.When the rn pressed to retract needle into device for safety, pieces of needle device dislodged across room (spring and plastic needle cap).Resource and md made aware and provided package and pieces.¿ no injury to patient.Additional information provided: 1.Please share the captured photo of the event if available.¿ no photo available.2.Can you please share the exact location of the leak ¿ the medication leaked out of the syringe per the rn.She did not provide further detail.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(4) - supplemental mdr - needle retraction failure (integra).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.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.

• Brand Name: BD SYRINGE INTEGRA 3ML LL W/NDL 25X5/8 RB
• Common Device Name: SYRINGE, ANTISTICK
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20296288
• Report Number: 1213809-2024-00657
• Device Sequence Number: 15253823
• Product Code: MEG
• UDI-Device Identifier: 30382903052692
• UDI-Public: (01)30382903052692(11)230822(17)280731(10)3234572
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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 Catalogue Number: 305269
• Device Lot Number: 3234572
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown