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 Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
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 4 bd threaded lock cannulas were cracked/damaged/deformed/bent.Product defect was noted during use.The following information was provided by the initial reporter: the customer is using this product only at nicu.The threaded lock cannula was too short to insert (short length).The customer has experienced this incident several times.
Event or Problem Description
It was reported that 4 bd threaded lock cannulas were cracked/damaged/deformed/bent.Product defect was noted during use.The following information was provided by the initial reporter: the customer is using this product only at nicu.The threaded lock cannula was too short to insert (short length).The customer has experienced this incident several times.
Additional Manufacturer Narrative
H.6.Investigation: three photos were received and evaluated.The photos depict four loose threaded lock pieces and single package with top web indicating batch #(b)(6), (p/n 303369).The four threaded lock pieces were all observed to have short cannula defect.One piece was confirmed to be from cav 43.Four physical samples were evaluated, upon inspection of the returned units it was found that all four units have short cannulas and are all from cavity 43.This is due to the core pins being pulled back into the part during the molding process.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.

• 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: 10370449
• Report Number: 1213809-2020-00516
• Device Sequence Number: 3860008
• Product Code: FPA
• 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): 09/24/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 09/24/2020
• 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