FDA Adverse Event Malfunction Summary report: N

BD CATHENA¿ BC STRAIGHT CATHETER

MDR report key: 8348648 · Received February 18, 2019

Report

Report Number: 8041187-2019-00156
Event Type: Malfunction
Date Received: February 18, 2019
Date of Event: January 29, 2019
Report Date: April 29, 2019
Manufacturer: BECTON DICKINSON MEDICAL (SINGAPORE)
Product Code: FOZ
UDI-DI: 00382903868049
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: DHR REVIEW WAS PERFORMED AND NO SIMILAR QN WAS RAISED. NO ABNORMALITY WAS OBSERVED THAT COULD HAVE INFLUENCED THE ISSUE. ONE SAMPLE WA RETURNED WITHOUT COVER AND ADAPTER FOR INVESTIGATION. SAFETY ACTIVATION FAILURE WAS OBSERVED. THE ADAPTER HAD BEEN REMOVED BUT THE TIP SHIELD WAS STILL IN THE HUB. THE PROBABLY ROOT CAUSE COULD BE DUE TO THE DAMAGED ADAPTER. HOWEVER, THE ROOT CAUSE COULD NOT BE CONFIRMED AS THE ADAPTER WAS NOT RETURNED FOR INVESTIGATION. CAPA#821876 WAS INITIATED.

Description of Event or Problem · 0

IT WAS REPORTED WITH THE USE OF THE BD CATHENA¿ BC STRAIGHT CATHETER THERE WAS AN ISSUE WITH SAFETY MECHANISM FAILED TO ENGAGE.

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR? A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED WITH THE USE OF THE BD CATHENA¿ BC STRAIGHT CATHETER THERE WAS AN ISSUE WITH SAFETY MECHANISM FAILED TO ENGAGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
139955	BD CATHENA¿ BC STRAIGHT CATHETER	INTRAVASCULAR CATHETER	FOZ	BECTON DICKINSON MEDICAL (SINGAPORE)		8208412	00382903868049

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other