MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303345
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that 2 bd¿ blunt plastic cannulas experienced device damage while still considered operable, and interlink damaging the connection port.The following information was provided by the initial reporter: these cannulas have proven to not be an acceptable product in our health system.From the day we put these on our shelves, we have received nothing but negative feedback and our end users have completely lost confidence in this product and we will no longer be able to utilize them.We have also received countless emails and phone calls regarding these.I was even getting calls throughout the weekends.Our supply chain specialists who supply our units continue to receive negative feedback as well.This rn was pulling up fentanyl in a vial with new blunt tip needles.The blunt tip punctured through the top of the vial, breaking it and causing the medication to spill, as well as difficulty pulling the medication out of the vial.When using blunt needle, rubber stopper pushed through the lid into the vial.Medication discarded/wasted and new vial was pulled from omnicell for patient administration.

• Brand Name: BD 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: 12422179
• Report Number: 1911916-2021-00928
• Device Sequence Number: 19764545
• Product Code: FMI
• UDI-Device Identifier: 30382903033455
• UDI-Public: 30382903033455
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 08/24/2021

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 Model Number: 303345
• Device Catalogue Number: 303345
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1