MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ LEVER LOCK CANNULA; INTRAVASCULAR ADMINISTRATION SET

Model Number	303370
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
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 "blood" was found on the bd¿ lever lock cannula lumen inside the unopened packaging.The following information was provided by the initial reporter: "i have a bd lever lock cannula (ref: (b)(4)) that came with blood inside of the package, on and inside the lumen of the cannula! so weird! the package is completely intact.".
Additional Manufacturer Narrative
H6: investigation summary one sample and six photos of lever lock cannula (p/n 303370) batch 9268577 were received and evaluated.The sample was received in a sealed package and the body of the thread lock has multiple spots of dark embedded foreign matter.The condition observed is non-conforming per product specification.Potential root cause for the embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.This type of defect is cosmetic and does not pose risk to the customer.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported that "blood" was found on the bd¿ lever lock cannula lumen inside the unopened packaging.The following information was provided by the initial reporter: "i have a bd lever lock cannula (ref: 303370) that came with blood inside of the package, on and inside the lumen of the cannula! soooo weird! the package is completely intact.".

• Brand Name: BD¿ LEVER LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 14228288
• Report Number: 1911916-2022-00225
• Device Sequence Number: 1700919
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K940697
• 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): 07/12/2022

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 Expiration Date: 09/30/2022
• Device Model Number: 303370
• Device Catalogue Number: 303370
• Device Lot Number: 9268577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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