MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303346
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that needle is breaking off with a bd syringe 3ml ll w/blunt plastic can.The following information was provided by the initial reporter: customer states needles are dull and when nurses attempt to pull medication from the vials the needle damages the vials because they do not puncture.Additional information provided by initial reporter: my er dept.Did not save any of the damaged syringes.I have removed this product from their dept.And have a box that i can send you.The manager says that while trying to insert the blunt plastic end into the vial of medicine, the tip starts to bend and then breaks off into the vial damaging the vial and not allowing for the extraction of the medication.Our med/surg.Dept.Is reporting that they too are having difficulty using this syringe due to the same problem.
Additional Manufacturer Narrative
H.6.Investigation: 1 opened resealed and 9 with original seal intact shelf cartons, as well as one plastic bag containing 13 loose sealed blister packages, were received.All product was identified to be from batch #9028859 (p/n 303346).The samples were 100% visually inspected for cannula tip configuration, flash and damage.No visual defects were observed.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.H3 other text : see h.10.
Event or Problem Description
It was reported that needle is breaking off with a bd syringe 3ml ll w/blunt plastic cann.The following information was provided by the initial reporter: customer states needles are dull and when nurses attempt to pull medication from the vials the needle damages the vials because they do not puncture.Additional information provided by initial reporter: my er dept.Did not save any of the damaged syringes.I have removed this product from their dept.And have a box that i can send you.The manager says that while trying to insert the blunt plastic end into the vial of medicine, the tip starts to bend and then breaks off into the vial damaging the vial and not allowing for the extraction of the medication.Our med/surg.Dept.Is reporting that they too are having difficulty using this syringe due to the same problem.

• Brand Name: BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• 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: 8901481
• Report Number: 1213809-2019-00840
• Device Sequence Number: 241093
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 303346
• Device Lot Number: 9028859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other