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

Catalog Number 980007

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/28/2023

Event Type  malfunction  

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 power-me had foreign matter.The following information was provided by the initial reporter; during the puncture, a foreign body was found inside the catheter; need for green claims, need for complaint response letter, need for complaint.Acceptance letter.

Event Description

No additional information provided.

Manufacturer Narrative

1.Production lot record check (lot#3016995) : 1) the product specification is (b)(6) , 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.Return sample have been received.The sample have been used.As checked under microscope, no fm in catheter been found per attached photo 1.In summary, the root cause cannot be confirmed, and plant will continue to pay attention to such complaint trends.

• 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: 18360936
• MDR Text Key: 331114031
• Report Number: 3014704491-2023-00832
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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