MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD THREADED LOCK CANNULA; INTRAVASCULAR ADMINISTRATION SET

Model Number	303369
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd threaded lock cannula leaked during use.The following information was provided by the initial reporter: leakage occurred from a injection site.Customer suspects the cannula part was broken.
Event or Problem Description
It was reported that bd threaded lock cannula leaked during use.The following information was provided by the initial reporter: leakage occurred from a injection site.Customer suspects the cannula part was broken.
Additional Manufacturer Narrative
H.6.Investigation: several photos and one used physical threaded lock sample were received.The sample was visually evaluated.No apparent molding defects were observed with the returned piece, which was from cavity 26.Damage was observed to both ears on the luer connection.Since the sample had been manipulated it is possible the observed small amount of damage to the luer ears were a result of user manipulation.It is unclear whether that is related to the reported leakage issue.The sample was forwarded to bd sandy for evaluation to confirm whether any molding defects were present.Upon visual examination, no defects were observed to the cannula.It was also determined that the cavity number for the sample is 26.Minor damage was observed to the luer threads indicative of being mated to a male luer lock device.The part was assembled with an interlink connecter in the large threaded end and leak tested with air at 8 psi under water per qcge-184 version c.No evidence of leakage was observed.The defect of leakage could not be confirmed and there is no physical nonconformity in the part that would cause leakage.The dhr for sublot number 8156644 has been reviewed.No related quality issues or process deviations were noted.
Event or Problem Description
It was reported that bd threaded lock cannula leaked during use.The following information was provided by the initial reporter: leakage occurred from a injection site.Customer suspects the cannula part was broken.
Additional Manufacturer Narrative
The following fields have been updated with additional information: f.10.Device codes: 1069.

• Brand Name: BD THREADED LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10047973
• Report Number: 1213809-2020-00300
• Device Sequence Number: 16914728
• Product Code: FMI
• UDI-Device Identifier: 30382903033691
• UDI-Public: 30382903033691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2020

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: 11/30/2024
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: 9340414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 04/22/2020; 04/22/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/20/2020; 06/30/2020
• 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