MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD MCKESSON BRANDS; CATHETER, FOLEY COUDE TIP LTX 16FR 5CC 16"

Catalog Number 16-LFOL516C

Device Problems Difficult to Remove (1528); Material Too Soft/Flexible (4007)

Patient Problem Genital Bleeding (4507)

Event Date 03/01/2023

Event Type  Injury  

Event Description

Customer reported that the tip of the catheter is too steep and too soft to insert.In one incident, there were problems getting out of the patient.Catheter had to be surgically removed and there was bleeding.

Manufacturer Narrative

The factory for amsino was incorrect on the initial filing and his been corrected with this supplemental submission.

• Brand Name: MCKESSON BRANDS
• Type of Device: CATHETER, FOLEY COUDE TIP LTX 16FR 5CC 16"
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO., LTD; no. 355 huazhe rd; songjiang export processing zo; shanghai, shanghai 21534 3; CH 215343
• MDR Report Key: 16703949
• MDR Text Key: 312909186
• Report Number: 1451040-2023-00018
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2023,04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 16-LFOL516C
• Device Lot Number: CAOA04-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/07/2023
• Distributor Facility Aware Date: 03/08/2023
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other