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	04/13/2020
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 the bd threaded lock cannula experienced product damage/deformation with the device still considered operable.Product defect was noted during use.The following information was provided by the initial reporter: a cannula was shorter than usual and the rubber part of the injection site didn't open.The route was occluded.
Additional Manufacturer Narrative
H.6.Investigation: no samples were received for evaluation.The complaint is confirmed based on previous investigations of the defect and material used for this lot.The supplier sub-assembly batch for the finished good batch 9323673 is the same as with the other related complaints batch 9316250.This condition occurs when the core pin is too hot causing it to pull the cannula as the core pin is retracted at the end of the molding cycle and prior to ejection.All quality checks for that lot were performed per established quality controls and passed (as evident from the dhr review), therefore there is no reason to suspect that cooling of the pin was interrupted for a long time.Retain samples for this lot were no longer available but retain samples from the lot molded in january 2020 were inspected: the defect was not observed.This further suggests that the reported defect was most likely a ¿blip¿, such as a temporary blockage of a cooling flow.
Event or Problem Description
It was reported that the bd threaded lock cannula experienced product damage/deformation with the device still considered operable.Product defect was noted during use.The following information was provided by the initial reporter: a cannula was shorter than usual and the rubber part of the injection site didn't open.The route was occluded.

• 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: 10022178
• Report Number: 1213809-2020-00282
• Device Sequence Number: 2937439
• 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): 05/07/2020

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: 9323673
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 05/07/2020
• 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