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 08/25/2020

Event Type  Injury  

Manufacturer Narrative

Medical 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.(b)(4).

Event Description

It was reported that the bd arterial cannula broke off in the patient, and a small surgical procedure was needed to remove the broken catheter piece.The following information was provided by the initial reporter, translated from (b)(6) to english: "as described in the message.When removing the catheter, the catheter is broken at the attachment.Part of the catheter remained in the patient." "additional small surgical procedure to remove the remaining catheter.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/9/2020.H.6.Investigation: one sample was received by our quality team for evaluation.A broken catheter was observed on the returned sample.When the sample was observed under a microscope, a clean cut was observed on the part-off surfaces.Therefore, the team was able to confirm the customer experience.A device history record could not be evaluated as the lot number is unknown.A simulation was conducted using scissors to cut the catheter tubing of an arterial cannula sample.This sample was also observed under a microscope, and a clean cut on the part-off area of the catheter tubing similar to that of the returned sample was observed.The broken catheter could have been caused by a sharp object such as scissors.The arterial cannula tube draw machine was reviewed, the machine parts that contact the catheter tubing are the machine grippers.However, the machine grippers have round flat surfaces with no sharp edges that could have caused the part-off in the catheter tubing.The arterial cannula assembly machine was reviewed, there is an automated vision inspection machine at the arterial cannula assembly machine which auto rejects any parts not meeting the lie distance requirement.If the catheter tubing is broken, its lie distance would most likely have failed and will automatically be rejected by the line.The user application was also reviewed, the verbatim mentions that the dressing was "removed with a scissors, while doing that there was a splashing bleeding from the puncture site." from the investigation, the catheter was most likely cut by a sharp object such as scissors during user application.H3 other text : see h.10.

Event Description

It was reported that the bd¿ arterial cannula broke off in the patient, and a small surgical procedure was needed to remove the broken catheter piece.The following information was provided by the initial reporter, translated from german to english: "as described in the message.When removing the catheter, the catheter is broken at the attachment.Part of the catheter remained in the patient." "additional small surgical procedure to remove the remaining catheter.".

• 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: 10551310
• MDR Text Key: 207501094
• Report Number: 8041187-2020-00580
• 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: 10/29/2020

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: Other
• Device Catalogue Number: 682245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/17/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention