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

Catalog Number 682245

Device Problem Break (1069)

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

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd arterial cannula 20g/45mm needle broken during / after use the following information was provided by the initial reporter: the patient's body was difficult to puncture, and the process was not smooth.He had the experience of repeated punctures.After the operation, it was found that the hose was broken in the body.After investigation, the broken tube was surgically removed.

Manufacturer Narrative

Based on the dhr review, there is an outgoing inspection to inspect for product damaged during the in-process inspection, no catheter tubing defect qn being raise for the assembly needle (an) batch used to produce this complaint batch.4 photos were received.Broken catheter was observed in the photos.No sample was received.If there was a sample received, the broken catheter can be investigated to determine its cause, the complaint will be re-open when there is a sample received.The complaint trend will be monitored.

Event Description

The patient's body was difficult to puncture, and the process was not smooth.He had the experience of repeated punctures.After the operation, it was found that the hose was broken in the body.After investigation, the broken tube was surgically removed.

• Brand Name: BD ARTERIAL CANNULA 20G/45MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18686316
• MDR Text Key: 335187854
• Report Number: 2243072-2024-00157
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382906822451
• UDI-Public: (01)00382906822451
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 682245
• Device Lot Number: 2355701
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention