MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 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	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 cathena 20gx1.00in straight bc leaked.The report is as follows, "on 8 out of 9 catheters, the anti-reflux valve failed.It was leaking upon insertion 3 incidents occurred on (b)(6) and then there were others that occurred on an unknown date happened on different patients but they did not have to re-stick the patients each time because the iv was still functional" this complaint is to capture the additional events on an unknown date.
Additional Manufacturer Narrative
Investigation: the complaint is unconfirmed as no sample/photo received.Qn history for past 12 months was reviewed, no similar qn raised.There was a capa raised for blood droplet formation at the luer end of the catheter adapter.Refer to capa#86125.Small id catheter tubing and small septum vents have been implemented to address the issue.
Event or Problem Description
It was reported that a cathena 20gx1.00in straight bc leaked.The report is as follows, "on 8 out of 9 catheters, the anti-reflux valve failed.It was leaking upon insertion 3 incidents occurred on 2/21 and then there were others that occurred on an unknown date happened on different patients but they did not have to re-stick the patients each time because the iv was still functional" this complaint is to capture the additional events on an unknown date.

• Brand Name: 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: 8418600
• Report Number: 8041187-2019-00226
• Device Sequence Number: 19393716
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• 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): 03/28/2019

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: 05/31/2021
• Device Catalogue Number: 386803
• Device Lot Number: 8116296
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 03/28/2019
• 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