MAUDE Adverse Event Report: BD (SUZHOU) BD POWERME MIDLINE CATHETER

Catalog Number 980017

Device Problem Break (1069)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was rpeorted that the powerme midline catheter was damaged.The following was translated from chinese to english: no blood return was seen at the time of your venipuncture, and when the catheter was withdrawn, it was found to be incomplete, and the tube is still in the patient's body.

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

1.Production lot record check (lot#3068441) : 1) the product specification is 22gx10cm, sku number is 980017, the production date is 2023/04, and lot quantity is 600.2) check the process test report and outgoing test report, the test results meet the product standards, no abnormalities.3) check production records for no nonconformities, deviations or rework activities.2.The returned sample has been received, the product has been used, and the broken portion catheter has not been received.According to the returned portion, the length of the broken catheter is estimated to be about 70mm.The section of the broken catheter has no white or deformation, and there is a v-shaped puncture notch, and the section is uneven, as shown in the attached pictures 2 and 3 3.Check the retained samples of the same batch of products that no abnormality for the catheter, as shown in attachment 1 a simulation test was carried out which was pulled by external force directly, and the section of the fracture was white with obvious deformation, as shown in the attached picture 4 cut the catheter with a sharp tool, and the section is smooth, without whitening and plastic deformation, as shown in the attached picture 5 the simulated cannula punctures the catheter and pulls it off, with v-shaped punctures and uneven sections, as shown in attached pictures 6 and 7 4.Summary: according to the normal operation procedure, the guide wire should be advanced after successful puncture, and the guide wire should be pushed to the end before the catheter is sent.When the catheter head exceeds the guide wire, it may be difficult to advance.When the catheter is pulled back, if the puncture angle is large, the needle will puncture the catheter, and the fracture section similar to the sample returned by the customer will appear after being pulled apart by external force.It is recommended that the customer follow the ifu instructions.After the catheter is advanced, do not directly withdraw the catheter while the needle remains in the catheter.If the catheter needs to be withdrawn, keep the needle and catheter simultaneously or withdraw the catheter after the needle is withdrawn, as shown in the attached ifu screenshot picture 8.H3 other text : see h10.

Event Description

No blood return was seen at the time of your venipuncture, and when the catheter was withdrawn, it was found to be incomplete, and the tube is still in the patient's body.The product is a sample.

• Brand Name: BD POWERME MIDLINE CATHETER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17916534
• MDR Text Key: 326278628
• Report Number: 3014704491-2023-00640
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 980017
• Device Lot Number: 3068441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• 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