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

Model Number	303369
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during use the tip of interlink breaks off with a bd threaded lock cannula.The following information was provided by the initial reporter, translated from (b)(6) to english: a needle was broken and hcp couldn't connect it.
Additional Manufacturer Narrative
H.6.Investigation: three photos were received and evaluated.Sample could not be sent due to covid-19 the photos depicted a single loose threaded lock piece.The cannula was observed to have been broken at the base and placed loosely on top of it.The defect appeared to extend to the luer lock connection which was indented.However, it was not clear whether there was a molding defect or damage to the luer and the cannula connections.There appeared to be some damage to the edge of the piece outside the connections.Cavity # could not be determined from the photos.Physical sample is necessary to evaluate the type of defect being observed in the photos and its potential cause.Without the physical sample, the defect and the potential root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that during use the tip of interlink breaks off with a bd threaded lock cannula.The following information was provided by the initial reporter, translated from japanese to english: a needle was broken and hcp couldn't connect it.

• 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: 9900899
• Report Number: 1213809-2020-00218
• Device Sequence Number: 16768437
• 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
• Report Date (Section B): 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: 9316250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/27/2020
• 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