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

Qn#(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: from the description and time interval of these complaints, it should be from the same customer which including changes on short tubing, the belt, the buckle and the drainage tube.We received such issues before and confirmed them one by one.As the descriptions in these complaints are similar to the previous ones, we combined several complaints for investigation.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.Changes on belt.We randomly selected the stock belts to test.When the state of the belt is shown in picture, we tried to pull it out and found that it can be pulled out from the side of the buckle plug with a lot of force.Therefore, we infer that when the assembling method of the belt is cd as shown below, it may be pulled out and cause damage if the belt is pulled forcefully.In addition, we tried to adjust the buckle assembling method during the test.After adjustment, it is picture as shown, which is seen different from cd.It is found that the buckle state of such as is very firm after pulling test, and it will not move, be pulled out and damaged.Use of buckle.Since we could not find a supplier that provided the same buckles as the customer before, we chose the buckles with the same overall design but slightly different appearance structure to match the product.The details are shown in the picture (picture cd is the proofing buckle, and picture@ is the existing buckle).From the perspective of actual use, we have confirmed the two buckles.In the process, we found some slight differences.The existing buckle is firmly connected in the locked state, but because the surface of it is relatively flat, the buckle can be eject by pressing the flat, which may lead to disconnect in the use.In addition, the buckle plug is relatively short, and may lead to disconnect by accidental touch.From the analysis of the buckle provided by customer in the proofing stage, its surface is relatively small and with concave and convex edges, which is not easy to cause disconnect in the use process.And its plug is also relatively long, it will not cause the buckle to fall off in the first time after accidental touch.After investigation, we confirm that the appearance and use of the existing buckles are slightly different from those provided by the customer in the proofing stage.But on the whole, the existing buckles can ensure the safety and effective use of the products.At present, we have found the buckle sample which consistent with the original customer sample, and we are waiting for the customer's final confirmation.Once confirmed, it can be replaced immediately.According to the tests, the product style we currently produce is slightly different from that provided by the customer in the proofing stage.The existing buckle is firmly connected in the locked state, but because the surface of it is relatively flat, the buckle can be eject by pressing the flat, which may lead to disconnect in the use.In addition, the buckle plug is relatively short, and may lead to disconnect by accidental touch.Based on the complaint received and the evaluation of buckles, there are two ways of assembling.The reason for the incident should be due to the inconsistent way in which some of the workers assembling.1.Revise the buckle assembly requirements immediately and train the assembly personnel.2.Keep track of such issue.3.At present, we have found the buckle sample which consistent with the original customer sample, and we are waiting for the customer's final confirmation.Once confirmed, it can be replaced immediately.

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: 13895831
• MDR Text Key: 288682816
• Report Number: 3004365956-2022-00021
• 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