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 Foreign Body In Patient (2687)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd¿ arterial cannula line fractured during use and left a "3 cm" piece in the patient's radial artery.As a result, the patient had to have surgical removal of the broken catheter piece under local anesthesia.The following information was provided by the initial reporter: "nurse was removing aline whilst applying pressure over radial artery.Line fractured and left about 3cm in the artery.This required surgical removal under local anaesthetic".

Manufacturer Narrative

Investigation: two photos were received by our quality team for evaluation.Visual inspection of the photo shows a broken catheter, confirming the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.There were no physical samples received for investigation of this complaint, the edges of the breakage could not be observed and investigated.The machine parts that come in contact with the catheter tubing are the machine grippers.However, the machine grippers have a round flat surface with no sharp edges that could cause part-off in the catheter tubing.The location of the broken off area in the photo does not coincide with the location where the machine grippers contact the catheter tubing.There is also an automated vision inspection machine at the arterial cannula assembly machine that auto-rejects any parts not meeting the lie distance requirement.If the catheter tubing is broke, its lie distance would most likely have failed and will automatically be rejected by the line.From the investigation, the root cause of this could not be determined.

Event Description

It was reported that the bd¿ arterial cannula line fractured during use and left a "3 cm" piece in the patient's radial artery.As a result, the patient had to have surgical removal of the broken catheter piece under local anesthesia.The following information was provided by the initial reporter: "nurse was removing aline whilst applying pressure over radial artery.Line fractured and left about 3cm in the artery.This required surgical removal under local anaesthetic".

• 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: 10301610
• MDR Text Key: 199666348
• Report Number: 8041187-2020-00420
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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 Catalogue Number: 682245
• Device Lot Number: 9206517
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention