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 No Patient Involvement (2645)

Event Date 12/04/2020

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 the bd" arterial cannula catheter tube was found damaged.The following information was provided by the initial reporter, translated from (b)(6) to english: "when preparing to use the product, the user found that the external catheter tube was deformed and the catheter tube was damaged".

Event Description

It was reported that the bd¿ arterial cannula catheter tube was found damaged.The following information was provided by the initial reporter, translated from chinese to english: "when preparing to use the product, the user found that the external catheter tube was deformed and the catheter tube was damaged".

Manufacturer Narrative

H.6.Investigation: one photo was received by our quality team for evaluation.From the photo, a defective / damaged catheter is observed on the tip of the catheter.Therefore, the team was able to confirm 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.From the damaged tip observation, the damaged tip is likely caused by a force acting from the tip end towards the housing direction.The arterial cannula assembly process was reviewed.There is a 100% inspection online lie distance inspection that will reject any parts failing the lie distance.The catheter lubrication process was reviewed.The lubrication process is lubricating the catheter tubing in a direction from the housing to the catheter tip.With the direction of the lubrication, the damaged tip could not have been caused by the lubrication process.The protection tube capping process was reviewed.A simulation was carried out by capping the protection in the offset position to find out if offset capping could cause similar damage on the catheter tip.After the evaluation, the catheter tip was visually observed, and no similar damage was observed on the catheter tip.Another simulation was carried out by pulling the cannula in the catheter tubing drawn upwards and exerting an upwards force to the tip of the catheter tubing.A similar damage was observed on the catheter tubing.If the protection tube was detached after the assembly process or during the packaging process, the damaged catheter may occur when the catheter tip hit against other parts or parts of the machine.However, according to the verbatim, the customer received the parts with the protection tube intact inside the packaging.Therefore, it is unlikely to have been caused by loosened / missing protection tube.Therefore, the root cause could not be determined.H3 other text : see h.10.

• 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: 11103459
• MDR Text Key: 225131398
• Report Number: 8041187-2020-00893
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 682245
• Device Lot Number: 0141811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1