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

Model Number	303390
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Investigation summary: it was reported by the facility representative that the needle does not pierce the top of the vial and a piece of rubber got inside the vial.To aid in the investigation, two photos were provided for evaluation by our quality team.One photo shows the packaging blister top web and the other photo shows the product in its packaging blister.It could be possible these defects occurred if the customer is not using the product as intended.This product is not designed to pierce stopper vials.A device history record review was completed for provided material number 303390, lot number 0202319.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defects.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.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 the cannula twinpak device had a difficult time piercing the vial, causing a piece of rubber to shear off into the medication.The following information was provided by the initial reporter: "the blunts don't pierce the top of the vials well.On monday one of the crna's got a piece of the rubber in the vial." "we had a site that reported that it caused coring and a small piece of rubber was noted in the syringe.".

• Brand Name: CANNULA TWINPAK DEVICE
• 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: 12365070
• Report Number: 1911916-2021-00877
• Device Sequence Number: 14424986
• Product Code: FMI
• UDI-Device Identifier: 30382903033905
• UDI-Public: 30382903033905
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K974006
• 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): 08/18/2021

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: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 303390
• Device Catalogue Number: 303390
• Device Lot Number: 0202319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1