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 Patient Involvement (2645)
Date of Event	06/19/2020
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.(b)(4).
Event or Problem Description
It was reported that the bd¿ threaded lock cannula connection was damaged before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the cannula connection part was damaged.".
Event or Problem Description
It was reported that the bd¿ threaded lock cannula connection was damaged before use.The following information was provided by the initial reporter, translated from japanese to english: "the cannula connection part was damaged.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples or photos were received for evaluation.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 9340415 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The supplier sub-assembly batch for the finished good batch 9323673 is the same as with the other related complaints batch 9316250 and others.Based on previous investigation from the cannula sub-assembly plant (bd sandy), the defect 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.Retained samples for this lot were no longer available but retained 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.No corrective actions are required at this time.H3 other text : see h.10.

• 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: 10253604
• Report Number: 1213809-2020-00453
• Device Sequence Number: 16994016
• 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): 07/30/2020

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: 9340415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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