MAUDE Adverse Event Report: AMSINO MEDICAL (SHANGHAI) CO., LTD. FOLEY CATHETER AMSURE 2-WAY STANDARD TIP 5 CC BALLOON 16 FR. SILICONE; CATHETER, RETENTION TYPE, BALLOON

Catalog Number AS41016

Device Problems Product Quality Problem (1506); Obstruction of Flow (2423); Improper Flow or Infusion (2954)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 08/29/2022

Event Type  malfunction  

Event Description

Pt has had discomfort at catheter site, complaining of severe pain at catheter site (b)(6) 2022.Has required frequent catheter (foley-urinary) changes due to malfunctioning of catheter "illegible" needed times one month - needed irrigation to keep catheter flowing: (b)(6) 2022.Cath needed changing.Patient had bleeding and pain with each change.Note: similar scenarios with two other patients, same cath.Foley catheter amsure 2-way.Standard tip 5cc balloon, 16 fr.Silicone coated latex.Amsino international mfr (b)(4).Ordered from mckesson (b)(4).Two other patients also having frequent blockages and pain.Same catheter.

• Brand Name: FOLEY CATHETER AMSURE 2-WAY STANDARD TIP 5 CC BALLOON 16 FR. SILICONE
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): AMSINO MEDICAL (SHANGHAI) CO., LTD.
• MDR Report Key: 15503081
• MDR Text Key: 300917184
• Report Number: MW5112319
• Device Sequence Number: 4
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2022
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: AS41016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White