MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.25IN STRAIGHT BC; IV CATHETER

Catalog Number 386804

Device Problem Difficult to Remove (1528)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.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 that the cathena 20gx1.25in straight bc experienced a safety failure causing a needle stick injury to a nurse.The following information was provided by the customer: consultant completed cannulation with cathena 18g x 32mm under ultrasound guidance.Consultant reported difficulty removing needle shield.It required force by herself & 3 nurses.Needle stick injury occurred once shield had been removed.

Manufacturer Narrative

Investigation: a lot# was not reported so a dhr could not be performed.The investigation was not able to confirm the what customer had experienced as no samples and no photos were received for evaluation.Hence, root cause is unable to be determined.

Event Description

It was reported that the cathena 20gx1.25in straight bc experienced a safety failure causing a needle stick injury to a nurse.The following information was provided by the customer: consultant completed cannualtion with cathena 18g x 32mm under ultrasound guidance.Consultant reported difficulty removing needle shield.It required force by herself & 3 nurses.Needle stick injury occurred once shield had been removed.

• Brand Name: CATHENA 20GX1.25IN STRAIGHT BC
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8453995
• MDR Text Key: 139958854
• Report Number: 8041187-2019-00254
• Device Sequence Number: 0
• Product Code: FOZ
• 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: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 386804
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other