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

Catalog Number 980007

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that bd powerme leaked the following information was provided by the initial reporter; the powerme with material# 980007 had leakage after successful puncture, which was located at the junction of the catheter and the catheter seat.The nurse only puncsed once, and no second puncture occurred.There was no damage to the patient, and the patient did not complain after re-puncture, but the hospital needed to compensate for the loss of the product.The patient was a hepatitis b patient, and the products after puncture had been destroyed and could not be recycled.

Manufacturer Narrative

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

Manufacturer Narrative

1.Production lot record check (lot#3016995) : 1) the product specification is 20gx10cm, sku number is 980007, the production date is 2023/02, 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.No sample or photo returned.3.Conducted leak test for retain sample, no abnormality found per attachment 1.As communicated with representative, no more detailed information received.The root cause can not be confirmed, plant will continue to pay attention to such complaint trends h3 other text : see narrative.

Event Description

No additional information provided.

• 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: 18340851
• MDR Text Key: 330977472
• Report Number: 3014704491-2023-00816
• 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: 12/31/2023

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 980007
• Device Lot Number: 3016995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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