MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY; INTRAVASCULAR CATHETER

Catalog Number 386806

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported while removing a bd cathena¿ safety iv catheter with bd multiguard¿ technology from a patient, the catheter tip was left in patient.An ultrasound was performed to find the catheter, and ¿patient monitoring¿.It was also reported that upon further investigation it appears that the catheter was cut by scissors while the nurse was removing the dressing.

Manufacturer Narrative

One actual sample returned for investigation.Cut catheter was observed on the returned sample.Manufacturing process has been reviewed, there is an online vision system at cell 1, station 33, which perform 100% inspection on catheter tip.Cut catheter/catheter without tip will be rejected by the vision system.According to the verbatim/event description, the catheter was cut by the nurse during the removal.Hence, the root cause is due to user error.Dhr review cannot be carried out as the lot number is unknown.

Event Description

It was reported while removing a bd cathena safety iv catheter with bd multiguard technology from a patient, the catheter tip was left in patient.An ultrasound was performed to find the catheter, and ¿patient monitoring¿.It was also reported that upon further investigation it appears that the catheter was cut by scissors while the nurse was removing the dressing.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER WITH BD MULTIGUARD¿ TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7851037
• MDR Text Key: 119375963
• Report Number: 8041187-2018-00338
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: 00382903868063
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

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
• Device Operator: Other
• Device Catalogue Number: 386806
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 08/13/2018
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention