MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 18FR

Catalog Number 170605-000180

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The devices have not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during an intervention in digestive surgery, we used 3 catheters ch 18 for urinary drainage; all 3 were porous or pierced in the patient's bladder.All 3 catheters were tested prior to use and none had an issue.Each time the bag fell from the patient.To continue the intervention we used a ch 16 catheter.There was no reported patient injury.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.One actual sample was returned for investigation.Based on the complaint description, it was reported that during an intervention in digestive surgery 3 catheters ch were used but all 3 were porous.Visual examination was conducted on the returned catheter and it was observed that the balloon had burst.However, there was no sign of material degradation or abnormalities observed.Investigation was conducted by reviewing the balloon part under highly magnification lens (dino lite) with 50x magnification on the actual sample.There were scratch marks observed on the balloon surface of the sample near the burst area.Our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Other remarks: based on the investigation conducted, burst balloon may have likely, happened due to in contact with sharp or pointed object leaving scratch marks on the balloon surface.These scratch marks may propagate and lead to burst.Therefore, this complaint could not be confirmed.

Event Description

It was reported that during an intervention in digestive surgery, we used 3 catheters ch 18 for urinary drainage; all 3 were porous or pierced in the patient's bladder.All 3 catheters were tested prior to use and none had an issue.Each time the bag fell from the patient.To continue the intervention we used a ch 16 catheter.There was no reported patient injury.

• Brand Name: BRILLANT 100% SIL FOLEY 18FR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 7148471
• MDR Text Key: 96214769
• Report Number: 8040412-2017-00267
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000180
• Device Lot Number: 17DT19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1