MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 1 BD BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	303345
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	04/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported the blunt plastic cannula is causing coring.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a vial and no other information could be obtained from the photo.It could be possible the customer is not using the product as intended.If the product is not meeting the customer¿s needs, it may be beneficial to contact the local bd sales, or marketing representative, for additional product options.As the lot provided is 'unknown,' a device history record review could not be completed.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 by customer that the bd interlink¿ blunt plastic cannula had cored.The following information was provided by the initial reporter: we recently had a stopper coring issue reported to us by our anesthesia team when they used the attached blunt point device to withdraw liquid medication from a drug vial.
Event or Problem Description
It was reported by customer that the bd interlink¿ blunt plastic cannula had cored.The following information was provided by the initial reporter : we recently had a stopper coring issue reported to us by our anesthesia team when they used the attached blunt point device to withdraw liquid medication from a drug vial.
Additional Manufacturer Narrative
H6: investigation summary it was reported the blunt plastic cannula is causing coring.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a vial and no other information could be obtained from the photo.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: 1 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
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14431574
• Report Number: 1911916-2022-00262
• Device Sequence Number: 17514847
• Product Code: FMI
• UDI-Device Identifier: 30382903033455
• UDI-Public: 30382903033455
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown