MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE-A¿ ARTERIAL CATHETER

Catalog Number 382805

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/31/2018

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd insyte-a¿ arterial catheter remained in the patients vascular system during removal.The lost part of the cannula was sonographically and radiologically documented and surgically removed under local anesthesia.There is no information regarding the outcome or effect on the patient at this time.

Manufacturer Narrative

Dhr review shows the product cat.(b)(4), lot # 7135264 were packed on (b)(6) 2017.The packed quantity was (b)(6).After reviewing the batch record, no abnormality found in the process.The inspection process and outgoing process both met the requirements.An actual sample and two representative samples were received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the sample provided.The catheter was noted to have a sloped break, additionally a cross-section of the tubing revealed an oval shape, as opposed to, the round cross-section of an unaffected representative samples.Used microscope to check, the catheter was oval.These two observations suggest the failure of this device is unrelated to the manufacturing process, and that the most probable root cause for this failure mode is that the catheter was broken or cut with an edged tool.

• Brand Name: BD INSYTE-A¿ ARTERIAL CATHETER
• Type of Device: ARTERIAL CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7296237
• MDR Text Key: 100926905
• Report Number: 1710034-2018-00043
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K942045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 382805
• Device Lot Number: 7135264
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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
• Patient Outcome(s): Required Intervention