MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER20 GA 1.25 IN; INTRAVASCULAR CATHETER

Model Number	386804
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported bd cathena safety iv catheter20 ga 1.25 in leaked during use.The following information was provided by the initial reporter: verbatim: ¿cannula leaked saline when flushed.User inserted cannula without any issue but couldn't advance it completely.She connected a posiflush to aid advancement of the cannula only (needle had been withdrawn) but when she flushed the saline "spurted out" through "a hole" in the cannula just proximal to the hub.¿.
Additional Manufacturer Narrative
H.6 investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified, and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.A photo of the defect could assist our quality team in their investigation.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
It was reported bd cathena safety iv catheter20 ga 1.25 in leaked during use.The following information was provided by the initial reporter: verbatim: ¿cannula leaked saline when flushed.User inserted cannula without any issue but couldn't advance it completely.She connected a posiflush to aid advancement of the cannula only (needle had been withdrawn) but when she flushed the saline "spurted out" through "a hole" in the cannula just proximal to the hub.¿.

• Brand Name: BD CATHENA SAFETY IV CATHETER20 GA 1.25 IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9746534
• Report Number: 8041187-2020-00102
• Device Sequence Number: 3432882
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 386804
• Device Catalogue Number: 386804
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/04/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/08/2020
• 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