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	04/27/2020
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 was "shorter than usual", and a "rubber part" of the injection site wouldn't open to let the infusion flow through during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "a cannula was shorter than usual and a rubber part of the injection site didn't open.Hcp couldn't flow infusion.".
Additional Manufacturer Narrative
H6.Investigation: two photos were received and evaluated.The photos depicted two threaded lock pieces side by side.One piece was observed to have no visible defects.One piece was observed to have a short cannula, which is rejectable per product specification.A closeup photo of cavity number on one of the pieces was 43 and residue was observed around the luer connection.A closeup of another piece showed cavity #9 with no residue visible.The most probable root cause is an overheated core pin, which was possibly caused by a temporary blockage of a cooling flow., 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, 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.A corrective action has been performed, preventative maintenance (pm) cycle on this mold has been changed to 7 days.This will ensure it has a pm performed before it is placed in storage.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.H3 other text : see h10.
Event or Problem Description
It was reported that the bd¿ threaded lock cannula was "shorter than usual", and a "rubber part" of the injection site wouldn't open to let the infusion flow through during use.The following information was provided by the initial reporter, translated from japanese to english: "a cannula was shorter than usual and a rubber part of the injection site didn't open.Hcp couldn't flow infusion.".

• 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: 10069941
• Report Number: 1213809-2020-00313
• Device Sequence Number: 2823380
• 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): 07/10/2020

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: Health Professional
• 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: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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