MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 24GX0.75IN WINGED BC; INTRAVASCULAR CATHETER

Model Number	386815
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
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 (b)(4).
Event or Problem Description
It was reported that cathena 24gx0.75in winged bc will not move forward causing the patient's vein to blow and blood to flow.This was discovered during use.The following information was provided by the initial reporter: material no: (b)(4), batch no: unknown.It was reported that when introducing the above cathlon into patient¿s vein the plastic cathlon will not move forward, causing the vein to blow.On a number of occasions blood flow on insertion when removing the needle occurs.
Additional Manufacturer Narrative
H.6.Investigation: 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.
Event or Problem Description
It was reported that cathena 24gx0.75in winged bc will not move forward causing the patient's vein to blow and blood to flow.This was discovered during use.The following information was provided by the initial reporter: material no: 386815 batch no: unknown it was reported that when introducing the above cathlon into patient¿s vein the plastic cathlon will not move forward, causing the vein to blow.On a number of occasions blood flow on insertion when removing the needle occurs.

• Brand Name: CATHENA 24GX0.75IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10382618
• Report Number: 8041187-2020-00473
• Device Sequence Number: 16844845
• Product Code: FOZ
• UDI-Device Identifier: 00382903868155
• UDI-Public: 00382903868155
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• 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): 08/26/2020

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: 386815
• Device Catalogue Number: 386815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/26/2020
• 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