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

Catalog Number 980021

Device Problem Break (1069)

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

Event Date 11/20/2023

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 powerme catheter broke the following information was provided by the initial reporter; product tube placement was broken during tube placement, unbroken tube was in the patient's body; samples can be returned, with photos provided; complaint response letter required, no letter of acceptance required; no green claims required.

Event Description

No additional information provided.

Manufacturer Narrative

1.Production lot record check (lot#3068424) : 1) the product specification is 20gx10cm, sku number is 980021, the production date is 2023/04, and lot quantity is (b)(4).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.There is a v-shaped puncture notch on section of catheter, the section of the broken catheter is not white and deformation.The guidewire is broken in catheter, and the catheter is punctured at the end of the broken guidewire.Refer to attached photo 1,2,3.3.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.The catheter was punctured by the cannula during repeated catheter advance, caused the guide wire being pinned by the cannula and the catheter at the punctured position, and being pulled off by external forces when the guidewire was withdrawn.5.Countermeasure: plant have summarized the report for catheter fracture and inform marketing colleagues to train customers.It is recommended that the customer follow the ifu instructions.After the catheter is advanced, do not directly withdraw the catheter or guidewire 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 narrative.

• Brand Name: BD POWERME
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18335994
• MDR Text Key: 330663925
• Report Number: 3014704491-2023-00814
• 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): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 980021
• Device Lot Number: 3068424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention