MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ TIP SYRINGE WITH BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303346
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the cannula of the bd luer-lok¿ tip syringe with blunt plastic cannula broke off when applying pressure to puncture the medication vial.The following information was provided by the initial reporter: "it is overly difficult to puncture the top of the medication vial with the blunt canula.  reviewing an event where an rn was trying to apply enough pressure and the cannula broke.  when it broke her hand suddenly pushed forward and she cut herself with the broken canula.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.Rn sustained cut to her hand.Did the event interrupt the administration of any medication, or cause a clinically significant delay in medication, that negatively impacted the patient? if yes, please provide details.Yes.She had to waste the medication and obtain a new vial and different syringe.Please describe any additional, unplanned medical or surgical intervention (e.G., additional/alternative medications, imaging, etc.) required to avoid patient harm, if not previously provided.N/a.Treatment was a bandaid.".
Additional Manufacturer Narrative
H6: investigation summary two photos were provided to our quality team for investigation.Bd syringes with blunt plastic cannula are specifically designed for use with pre-slit injection sites.They are not compatible with other injection sites.Since the photos received did not indicate proper usage of the syringe a potential root cause could not be defined, and corrective actions are not necessary.It is likely based on the photos and customer verbatim that this product was not being used for its intended application.H3 other text : see h10.
Event or Problem Description
It was reported that the cannula of the bd luer-lok¿ tip syringe with blunt plastic cannula broke off when applying pressure to puncture the medication vial.The following information was provided by the initial reporter: "it is overly difficult to puncture the top of the medication vial with the blunt canula.  reviewing an event where an rn was trying to apply enough pressure and the cannula broke.  when it broke her hand suddenly pushed forward and she cut herself with the broken canula.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.Rn sustained cut to her hand.Did the event interrupt the administration of any medication, or cause a clinically significant delay in medication, that negatively impacted the patient? if yes, please provide details.Yes.She had to waste the medication and obtain a new vial and different syringe.Please describe any additional, unplanned medical or surgical intervention (e.G., additional/alternative medications, imaging, etc.) required to avoid patient harm, if not previously provided.N/a.Treatment was a bandaid.".

• Brand Name: BD LUER-LOK¿ TIP SYRINGE WITH BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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 ; 8448235433
• MDR Report Key: 16963116
• Report Number: 1911916-2023-00327
• Device Sequence Number: 5243724
• Product Code: FMI
• UDI-Device Identifier: 00382903033461
• UDI-Public: 00382903033461
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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
• Report Date (Section B): 06/05/2023

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: 303346
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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