MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 20G X 1.77IN (1.1 X 45 MM) ARTERIAL CANNULA WITH FLOWSWITCH

Catalog Number 682245

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 an unspecified number of 20g x 1.77 in (1.1 x 45 mm) arterial cannula with flow switch experienced a needle the was broken/detached during use.Patient experienced serious injury in the form of medical intervention when the tubing from the device remained embedded within the patient.An attempt was made by a physician to remove the tubing from the patient but was unsuccessful.No additional information currently available.The following information was provided by the initial reporter: in the case of one patient, when the arterial cannula was removed for unexplainable reasons, the cannula tube is broken off and remains in the vessel! the patient is then referred to dr who has been relocated to remove the tube from the artery.Unfortunately, the doctors were not able to find the tubing note: size 3 cm by means of the doppler control, but did not remove it and are still in the patient in the artery!.

Manufacturer Narrative

H.6.Investigation summary: there were no samples or photos available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this event but without a sample no corrective actions could be identified.Arterial cannula tube draw machine.The machine parts that contact the catheter tubing were the machine grippers.However, the machine grippers have round flat surface with no sharp edges that could cause the tubing to be broken.The location of the breakage at 3cm as mentioned in the verbatim does not coincide with the location where the machine grippers contact with the catheter tubing.Arterial cannula assembly machine.No machine parts were in contact with the catheter tubing at 3cm.There is an automated vision inspection machine at the arterial cannula assembly machine, and it will auto reject any parts not meeting the lie distance requirement.If a part has broken catheter tubing, its lie distance would most likely have failed and will automatically be rejected by the line.The customer¿s experience on broken catheter could not be established as there is no batch number provided and no sample returned for investigation.

Event Description

It was reported that an unspecified number of 20g x 1.77in (1.1 x 45 mm) arterial cannula with flowswitch experienced a needle the was broken/detached during use.Patient experienced serious injury in the form of medical intervention when the tubing from the device remained embedded within the patient.An attempt was made by a physician to remove the tubing from the patient but was unsuccessful.No additional information currently available.The following information was provided by the initial reporter: in the case of one patient, when the arterial cannula was removed for unexplainable reasons, the cannula tube is broken off and remains in the vessel! the patient is then referred to dr who has been relocated to remove the tube from the artery.Unfortunately, the doctors were not able to find the tubing note: size 3cm by means of the doppler control, but did not remove it and are still in the patient in the artery!.

• Brand Name: 20G X 1.77IN (1.1 X 45 MM) ARTERIAL CANNULA WITH FLOWSWITCH
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9135755
• MDR Text Key: 166749563
• Report Number: 8041187-2019-00771
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other