MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ 20GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386803
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2019
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 a bd cathena¿ 20gx1.00in straight bc had a needle break.The following was reported, "material no: 386803 batch no: 8086304.It was reported that hub and needle separated from the catheter staying in the patient.Per incident report: patient was early 50s, former iv drug user, had good vein in right ac, put tourniquet on, successful access, advanced the catheter, when pulled back, pink hub came back with the needle resulting in catheter separating from the hub and staying in the patient.Xxxxxx then pinched end of catheter that was sticking out of patient's arm to remove it.Then applied pressure and gauze, alcohol swab and cleaned work area due to blood exposure.".
Additional Manufacturer Narrative
Investigation: a review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the production of the reported batch.1 photo and 1 representative samples was returned for evaluation.The investigation was not able to confirm the what customer had experienced as the sample pass both visual inspection and cathena ¿ separate force.Hence, root cause is unable to be determined.
Event or Problem Description
It was reported that a bd cathena¿ 20gx1.00in straight bc had a needle break.The following was reported, "material no: 386803 batch no: 8086304 it was reported that hub and needle separated from the catheter staying in the patient.Per incident report: patient was early 50s, former iv drug user, had good vein in right ac, put tourniquet on, successful access, advanced the catheter, when pulled back, pink hub came back with the needle resulting in catheter separating from the hub and staying in the patient.Xxxxxx then pinched end of catheter that was sticking out of patient's arm to remove it.Then applied pressure and gauze, alcohol swab and cleaned work area due to blood exposure.".

• Brand Name: BD CATHENA¿ 20GX1.00IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8471605
• Report Number: 8041187-2019-00267
• Device Sequence Number: 19200432
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/24/2019

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 Expiration Date: 03/31/2021
• Device Catalogue Number: 386803
• Device Lot Number: 8086304
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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