MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA

Catalog Number 682245

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a breakage occurred during use with a bd arterial cannula.The following information was provided by the initial reporter, "when removing the arterial catheter, the catheter part in the artery broke off, and the longest part remained in the patient's artery.The remaining part of the catheter that was pulled out, show that the end where it broke off, is "flat", indicating it has been kinked inside the artery, is has been angled inside and broke at what then became a weak point.The same thing happened 2 weeks ago, but the nurse removing it at that time was not a 100 % sure she could have cut the catheter under removal, so they did not report it to us.According to one of the surgeons the patient had to be taken by ambulance from icu to (b)(6) hospital, where specialized vessel surgeons had to remove the 4 cm long remaining part of the catheter from arteria radialis.This was of course a very disturbing and substantial extra strain for a patient who had already been through a large abdominal operation." 2 occurrences were reported.

Manufacturer Narrative

Investigation: one actual, used sample was received by our quality team for evaluation.Upon visual inspection of the sample received the customers reported failure can be verified.The remaining catheter tubing is estimated to be 0.5cm in length, additional magnification of the tubing was performed with a kink and a v-shaped cut observed.A device history record review found no non-conformances associated with this issue during production of this batch.The quality team then simulated this failure by taking a new arterial cannula, pierce the needle through the cannula which created the v-shaped cut, then the pierced through arterial cannula sample was then secured down by hand near the pierced through area and then the tubing was kinked left and right several times near the pierced area and the catheter broke.Based on the quality team's investigation, the catheter breaking is most likely cause by the v-shaped cut on the catheter tubing.The manufacturing process was reviewed for areas that could have caused the v-shaped cut and no manufacturing process was found which could have caused the v-shaped cut.The v-shaped cut most likely occurred due to the needle piercing through the cannula which may have happened outside of the manufacturing process.

Event Description

It was reported that a breakage occurred during use with a bd arterial cannula.The following information was provided by the initial reporter, "when removing the arterial catheter, the catheter part in the artery broke off, and the longest part remained in the patient's artery.The remaining part of the catheter that was pulled out, show that the end where it broke off, is "flat", indicating it has been kinked inside the artery, is has been angled inside and broke at what then became a weak point.The same thing happened 2 weeks ago, but the nurse removing it at that time was not a 100 % sure she could have cut the catheter under removal, so they did not report it to us.According to one of the surgeons the patient had to be taken by ambulance from icu to vestfold hospital, where specialized vessel surgeons had to remove the 4 cm long remaining part of the catheter from arteria radialis.This was of course a very disturbing and substantial extra strain for a patient who had already been through a large abdominal operation." 2 occurrences were reported.

• Brand Name: BD ARTERIAL CANNULA
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9245692
• MDR Text Key: 168613279
• Report Number: 8041187-2019-00850
• Device Sequence Number: 1
• Product Code: DWF
• 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: 11/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 682245
• Device Lot Number: 9145884
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention