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

Catalog Number 682245

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

A 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 an unspecified number of bd arterial cannulas experienced catheter kinking/bent during infusion.Product defect was noted during use.The following information was provided by the initial reporter: 24-48 hours after cannula insertion it loses it's function.It does not show the blood pressure.When they remove the cannula, they notice that it was knicked or curved.They have been noticing the same problem for the past two months in 50% of used cannulas.They are not sure if the problem occured in the same lot.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/3/2020.H.6.Investigation: three representative samples were received by our quality team for evaluation.All 3 representative samples were visually inspected on the following: damage on the silicone tubing, burr/flashes on the catheter tip, damage on the catheter tip, kink on the catheter tubing, other defects on catheter tubing, foreign matter in fluid path.No abnormality was observed on any of the samples.After the above visual inspection, the needle grip assembly of the samples were removed, and the catheter was subjected to another round of visual inspection to inspect the sample categories.No abnormality was observed once again on all samples.3 of the catheter samples from the above inspection were sent for x-ray analysis to check if there any concentricity issues in the catheter tubing area.If one section of the interior of the tubing wall has a thinner wall, that section will kink more easily.No concentricity issues were observed throughout the tubing during x-ray scans.Floswitch button operations force inspection was carried out on all 3 of the catheter samples.All results were within specification.Flowrate testing and kink flow rate testing was conducted on all 3 of the samples.All results were within specification.The incident could not be verified.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.Based on the investigation, no probable root cause could be determined due to no issues being observed.

Event Description

It was reported that an unspecified number of bd arterial cannulas experienced catheter kinking/bent during infusion.Product defect was noted during use.The following information was provided by the initial reporter: 24-48 hours after cannula insertion it loses it's function.It does not show the blood pressure.When they remove the cannula, they notice that it was nicked or curved.They have been noticing the same problem for the past two months in 50% of used cannulas.They are not sure if the problem occured in the same lot.

• 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: 10106752
• MDR Text Key: 195710203
• Report Number: 8041187-2020-00294
• 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: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: 9173743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/01/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other