MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 20 GA 1.00 IN; N/A

Model Number	386803
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd cathena safety iv catheter bd multiguard technology 20 ga 1.00 in had a leak.The following information was provided by the initial reporter: "there's a hole about 3mm from the guard.The infused fluid passes through this hole and not into the venous catheter.Removing the material and inserting a new catheter.".
Event or Problem Description
It was reported that bd cathena safety iv catheter bd multiguard technology 20 ga 1.00 in had a leak.The following information was provided by the initial reporter: "there's a hole about 3mm from the guard.The infused fluid passes through this hole and not into the venous catheter.Removing the material and inserting a new catheter.".
Additional Manufacturer Narrative
D.10 device available for eval yes, returned to manufacturer on: 2020-02-27.H.6.Investigation summary: one sample was received by our quality team for evaluation.Upon visual inspection it was observed that there was a cut found near the adapter along with catheter tip integrity; therefore, the incident could be verified.As there is no batch number, we are unable to perform a more detail investigation as dhr was not performed.The catheter tip integrity could have occurred during product application when the product was manipulated.The cut near the adapter was most likely caused at the feeder slots when the catheter is feed through a tube drum.There are sharp edges on the tube drum feeder slots.

• Brand Name: BD CATHENA SAFETY IV CATHETER BD MULTIGUARD TECHNOLOGY 20 GA 1.00 IN
• Common Device Name: N/A
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9727977
• Report Number: 8041187-2020-00094
• Device Sequence Number: 755460
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• 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): 05/04/2020

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: Other
• Device Model Number: 386803
• Device Catalogue Number: 386803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/04/2020
• 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