MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd 3ml syringe with luer-lok tip with vial access cannula experienced a needle that broke.The following information was provided by the initial reporter: material no.: 303401.Batch no.: 1069247.The issue with the blue capped cannula occured 5/9.The product was the 3ml bd luer lok tip with vial access cannula.As the employee was attempting to put the access cannula into the vial, she met resistance.She tried to push harder and the access cannula broke off.Her hand slipped and she lacerated a finger on the other hand.She had to cleanse and cover the cut.But no further medical interventions was needed.It still was healing when i saw the injury a few days later.
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.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.It is not clear from verbatim whether the medication vial had the correct septum when the vial access device was attempted to be used.Per product specification: - the product is to be used on preslitted interlink injection sites after taking medication out of single dose drug vials (not compatible with conventional injection sites).H3 other text : see h10.
Event or Problem Description
It was reported that the bd 3ml syringe with luer-lok tip with vial access cannula experienced a needle that broke.The following information was provided by the initial reporter: material no.: 303401 batch no.: 1069247.The issue with the blue capped cannula occured 5/9.The product was the 3ml bd luer lok tip with vial access cannula.As the employee was attempting to put the access cannula into the vial, she met resistance.She tried to push harder and the access cannula broke off.Her hand slipped and she lacerated a finger on the other hand.She had to cleanse and cover the cut.But no further medical interventions was needed.It still was healing when i saw the injury a few days later.

• Brand Name: BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11980710
• Report Number: 1213809-2021-00420
• Device Sequence Number: 3249924
• Product Code: FMI
• UDI-Device Identifier: 30382903034018
• UDI-Public: 30382903034018
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K924439
• 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): 06/11/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 303401
• Device Catalogue Number: 303401
• Device Lot Number: 1069247
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1