MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ARTERIAL CANNULA 20G/45MM; INTRAVASCULAR CATHETER

Catalog Number 682245

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd arterial cannula 20g/45mm were kinked during infusion.The following information was provided by the initial reporter: "aterial catheter kinked ".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-08.Investigation summary: five photos and four samples, one used and three representative samples, were received by our quality team for evaluation.All five photos show the kinked catheter.The used sample, which was returned in a rubber glove, was subjected to visual inspection.Two kinks were observed on the used catheter tubing.One kink is approximately 1 cm away from the nose of the housing and the second is near the nose of the housing.The representative samples were visually inspected on the catheter tubing before and after removing the cannula from the catheter near the nose of the housing and approximately 1 cm away from the nose of the housing.No kink was observed on the representative samples.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.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 a round flat surface with no sharp edges that could cause a kink in the catheter tubing.The arterial cannula assembly machine was reviewed, 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 the catheter tubing has a kink, the lie distance would most likely have failed and will automatically be rejected by the line.The returned actual sample was returned in a rubber glove without a protection tube.It is unknown if the catheter tubing of the sample could have been damaged by the packaging during delivery.Based on the investigation, the root cause for the kink / bend seen on the actual sample and returned photos could not be determined.H3 other text : see h10.

Event Description

It was reported that bd arterial cannula 20g/45mm were kinked during infusion.The following information was provided by the initial reporter: "aterial catheter kinked ".

• Brand Name: BD ARTERIAL CANNULA 20G/45MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12872456
• MDR Text Key: 281858365
• Report Number: 8041187-2021-01006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: 1141419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1