MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH 100%SILICONE 2WAY 5CC 16FR; FOLEY CATHETER

Catalog Number 170605160

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2015

Event Type  malfunction  

Event Description

The hosp reported the following incident: the catheter was inserted by the nurse and the balloon was inflated with 10ml of sterile water.Many hours later, the nurse found the balloon split, and as a result the catheter had to be replaced.There were no clinical consequences for the pt as a result of the incident, and hospitalization was not prolonged as a result of it either.No pt injury reported.

Manufacturer Narrative

Qn # (b)(4).The device sample was not received by the manufacturer at the time of this report.See scanned page.

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The returned sample was carefully removed from polybag and visually inspected.The sample appeared to be in good condition except that the balloon was split.Closer examination on the split balloon area under dino -lite, a high magnification microscope (20x magnification) revealed scratch marks near the tear region.In our standard operating procedure the raw balloons are subjected to 100% visual inspection using magnification lens.Defective raw balloon will be culled out before sent to the next process, then tested for leaks in the catheter system.Products that pass this test will be subjected to the next process.Based on the investigation and testing conducted on the actual sample, the split balloon root cause could not be identified.Therefore, we could not confirm this complaint as stated.

Event Description

The hospital reported the following incident: the catheter was inserted by the nurse and the balloon was inflated with 10ml of sterile water.Many hours later the nurse found the balloon split, and as a result the catheter had to be replaced.There were no clinical consequences for the patient as a result of the incident, and hospitalization was not prolonged as a result of it either.No patient injury reported.

• Brand Name: RUSCH 100%SILICONE 2WAY 5CC 16FR
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; p.o. box 28; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4820864
• MDR Text Key: 5841492
• Report Number: 8040412-2015-00125
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

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?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 170605160
• Device Lot Number: 14JE42
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1