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

Catalog Number 682245

Device Problems Complete Blockage (1094); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2021

Event Type  Injury  

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 arterial cannula 20g/45mm was damaged.The following information was provided by the initial reporter: on (b)(6) a patient is operated on, the patient has an arterial needle during surgery.Staff responsible for the patient during surgery state that the arterial needle has functioned properly.The anesthetist who inserted the needle states that it was inserted without an ultrasound remark.Only one stick, no "looking for artery".Post-operatively, uva states that the arterial catheter has not been completely stable, misleadingly high and low measured values, unsatisfactory appearance of the artery curve.They switch to non-invasive blood pressure measurement.Once the arterial catheter is to be phased out, the following happens according to description of on-duty anesthesia nurse at uva.At uva, an anesthetic nurse will remove the arterial needle.There is a nearby pvk next to the arterial needle, on the underside of the wrist.Both needles (arterial catheter and pvk) are winding with the same wrap, self-adhesive.The bandage ( in swedish linda) is difficult to find out why anesthesia- nurse decides to cut up the bandage.Hen cuts along the direction of the arm and has one of his fingers under the wrap between the arterial needle and scissors to prevent access to the arterial needle.Hen removes the torn linden.Iv fix bandage (bandage to secure arterial needles or pvk) is attached to iv fix for the arterial needle, anesthetic nurse parts, with only fingers, the iv fix bandages.Then remove iv fix completely from arterial needle.The arterial needle is still with some resistance.To get rid of it, it had to be pulled straight up with light force.The arterial needle releases but hen only gets the "house" in hens hand.When this is discovered, an anesthetist is contacted.The patient is operated on (reported as a puncture of the radial artery and thrombectomy a brachialis) the next day to remove the remaining arterial catheter remains from the artery.

Event Description

It was reported that arterial cannula 20g/45mm was damaged.The following information was provided by the initial reporter: on (b)(6), a patient is operated on, the patient has an arterial needle during surgery.Staff responsible for the patient during surgery state that the arterial needle has functioned properly.The anesthetist who inserted the needle states that it was inserted without an ultrasound remark.Only one stick, no "looking for artery".Post-operatively, uva states that the arterial catheter has not been completely stable, misleadingly high and low measured values, unsatisfactory appearance of the artery curve.They switch to non-invasive blood pressure measurement.Once the arterial catheter is to be phased out, the following happens according to description of on-duty anesthesia nurse at uva.At uva, an anesthetic nurse will remove the arterial needle.There is a nearby pvk next to the arterial needle, on the underside of the wrist.Both needles (arterial catheter and pvk) are winding with the same wrap, self-adhesive.The bandage ( in swedish linda) is difficult to find out why anesthesia- nurse decides to cut up the bandage.Hen cuts along the direction of the arm and has one of his fingers under the wrap between the arterial needle and scissors to prevent access to the arterial needle.Hen removes the torn linden.Iv fix bandage (bandage to secure arterial needles or pvk) is attached to iv fix for the arterial needle, anesthetic nurse parts, with only fingers, the iv fix bandages.Then remove iv fix completely from arterial needle.The arterial needle is still with some resistance.To get rid of it, it had to be pulled straight up with light force.The arterial needle releases but hen only gets the "house" in hens hand.When this is discovered, an anesthetist is contacted.The patient is operated on (reported as a puncture of the radial artery and thrombectomy a brachialis) the next day to remove the remaining arterial catheter remains from the artery.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-09.Investigation summary: two photos and one sample were received by our quality team for evaluation.From the photos and the sample, a broken catheter was observed.Both ends of the part-off surface of the catheter was examined under the scope, a clean cut was observed on the part-off surface.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.A simulation was conducted using scissors to cut the catheter tubing of an arterial cannula sample.The part-off end of the catheter tubing was observed under a scope, a clean cut was observed on the part-off area which is similar to that of the returned sample.Therefore, the broken catheter could have been caused by a sharp object such as scissors.The arterial cannula tube draw machine was reviewed, and the machine parts that contact the catheter tubing are the machine grippers, these grippers have a round flat surface with no sharp edges that could cause this nonconformance in the catheter tubing.The arterial cannula assembly machine was reviewed, and 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 is broken, its lie distance would most likely have failed and will automatically be rejected by the line.The customer verbatim mentions that ¿the bandage (in swedish linda) is difficult to find out why anesthesia-nurse decides to cut up the bandage.¿ the catheter could most likely have been cut by a sharp object such as scissors during user application.Therefore, the broken catheter could have occurred outside the manufacturing process.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: ARTERIAL CANNULA 20G/45MM
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11742633
• MDR Text Key: 264053199
• Report Number: 8041187-2021-00357
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 07/02/2021

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: 0022352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention