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

Model Number	303369
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2020
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 2 bd threaded lock cannulas were clogged/occluded or experienced flow issues.Product defect was noted during use.The following information was provided by the initial reporter: products didn't pass water.
Additional Manufacturer Narrative
H.6.Investigation: multiple photos and two sealed shelf cartons containing 100 threaded lock pieces each were received, confirmed to be from batch #9323673 (p/n 303369).The samples were visually evaluated.Both cartons were confirmed to have defective pieces with the short cannula condition for a total of 25 out of the 200 pieces inspected.The short cannula condition is rejectable per product specification.The affected cavities identified during inspection include: #1, 10, 28, 43.In addition to short cannula, 20 pieces were observed to have attached flash on cannula within acceptable limits per product specification.Finally, 1 piece was found to have damage resulting in slight bending of the luer lock and cannula connections.A potential root cause for damage to one piece is associated with the assembly process.The one damaged piece is within aql for this product per product specification for this batch.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9323673 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.
Event or Problem Description
It was reported that 2 bd threaded lock cannulas were clogged/occluded or experienced flow issues.Product defect was noted during use.The following information was provided by the initial reporter: products didn't pass water.

• 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: 9901388
• Report Number: 1213809-2020-00221
• Device Sequence Number: 14077764
• 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: 11/30/2024
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: 9323673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• 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