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

Model Number	303346
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 the blunt plastic cannula of the bd luer-lok¿ tip syringe would not pierce through the stopper easily, bending/deforming as a result and pushing the stopper into the medication vial.The following information was provided by the initial reporter: "the blunt tip does not pass through most rubber stopper easily, you have to use excessive force that either bends the tip or pushes the stopper into the vial.Not sharp enough to do the job.It is a pt safety".
Additional Manufacturer Narrative
H6: investigation summary customer reported that "the blunt tip does not pass through most rubber stopper easily, needs excessive force that either bends the tip or pushes the stopper into the vial." potential root cause for the reported failure appears to be related to customer awareness of the product¿s purpose and improper use of the product.Please note, per product specification bd® syringe with blunt plastic cannula provides sterile needleless access into: 1.Vials designed for needleless access and pre-slit septum vial adapters for the withdrawal and measurement of fluids.2.Pre-slit septum iv systems for dispensing fluids.Dhr review is not required due to the complaint being for the design of the product and not a true defect.H3 other text : see h10.
Event or Problem Description
It was reported that the blunt plastic cannula of the bd luer-lok¿ tip syringe would not pierce through the stopper easily, bending/deforming as a result and pushing the stopper into the medication vial.The following information was provided by the initial reporter: "the blunt tip does not pass through most rubber stopper easily, you have to use excessive force that either bends the tip or pushes the stopper into the vial.Not sharp enough to do the job.It is a pt safety".

• 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
• MDR Report Key: 12422382
• Report Number: 1911916-2021-00932
• Device Sequence Number: 17075199
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 09/06/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 303346
• Device Catalogue Number: 303346
• Device Lot Number: 1089743
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1