MAUDE Adverse Event Report: BECTON DICKINSON 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	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.
Event or Problem Description
It was reported that the bd threaded lock cannula experienced leakage at the connection site prior to use.The following information was provided by the initial reporter: saline leaked from a connection.
Additional Manufacturer Narrative
H.6.Investigation summary : multiple photos were received and evaluated.The photos depicted a single threaded lock piece from cavity 43 by itself and connected to a transfer tubing with a syringe at one end.Residue was observed on the luer end of the threaded lock piece with no molding defects visible at that end.The sample, however, was observed to have a short cannula condition, which is rejectable per product specification.A potential root cause for short cannula is associated with the defective material from supplier.Short cannula defect was recently investigated in pr# 1408669.However, batch # is required to determine whether this samples is within the same scope as previously investigated.Unfortunately, a definitive root cause or corrective actions is necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd threaded lock cannula experienced leakage at the connection site prior to use.The following information was provided by the initial reporter: saline leaked from a connection.

• Brand Name: BD THREADED LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10012345
• Report Number: 2243072-2020-00703
• Device Sequence Number: 13972307
• 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): 05/27/2020

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 Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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