MAUDE Adverse Event Report: TELEFLEX MEDICAL BELLY BAG; COLLECTOR, URINE, (AND ACCESSO

Catalog Number B1000

Device Problem No Flow (2991)

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

Event Date 12/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

On (b)(6) 2021 i had two belly bags with short tubing.One took me to er.I have the printed review of my visit where it proves i was not voiding because the bag was malfunctioning and not filling.

Manufacturer Narrative

(b)(4).We have proceeded the following investigations after receiving the complaints: for the item of b-1000, there has been no change since we start making a proof and put it into production.Based on the customer feedback, we compared and confirmed the existing products with the samples provided by customers in the proofing stage one by one.We compared the existing product with proofing sample.It can been seen that they do have differences.The drainage tube of existing product is slightly longer than the proofing samples.At that time, we considered the drainage tube in the actual use of the product, so we lengthened the tube to facilitate the folding and drainage, and it will not affect the use of the product , nor will it cause harm to patients.According to the tests, the product style we currently produce is slightly different from that provided by the customer in the proofing stage.However, there has been no change on the product since we got the customer's confirmation and started production.Each process of the existing products has been effectively confirmed, they are safe and effective.

Event Description

On (b)(6) 2021 i had two belly bags with short tubing.One took me to er.I have the printed review of my visit where it proves i was not voiding because the bag was malfunctioning and not filling.

• Brand Name: BELLY BAG
• Type of Device: COLLECTOR, URINE, (AND ACCESSO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13895658
• MDR Text Key: 297683602
• Report Number: 3004365956-2022-00020
• Device Sequence Number: 1
• Product Code: KNX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: B1000
• Device Lot Number: 20210728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.