MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-31 for FOLEY CATHETER WITH TEMPERATURE SENSOR 81-080412 manufactured by Deroyal Industries, Inc..
[6255571]
It concerned a urinary catheter that was introduced into a female pt in the operating room. No type or lot is known at this moment. It was a white catheter with temperature sensor. Within 24 hours after introduction, the catheter was removed with 3ml still left in the balloon. That last few milliliters was not able to be removed. This caused slight discomfort to the pt. No verification was done regarding the type of fluid with which the balloon was inflated. Further inspection of the catheter after removal was done, and it appeared that the lumen from the catheter to the balloon (at the point of the balloon in the side wall of the catheter) was very small. It appears the lumen was not punched thoroughly. Comparison was done with a regular blue catheter, and in the blue catheter, the lumen seemed much larger.
Patient Sequence No: 1, Text Type: D, B5
[14086883]
Investigation findings: when the report issue was received, the lot number was not identified. Additional attempts have made to obtain the lot number info. These attempts were unsuccessful in positively identifying the lot in which the issue occurred. The actual sample in which the issue occurred was available for eval, and the internal complaint handling procedure was followed due to the product being contaminated. A decision was made not to ship the contaminated product, and a request was submitted for decontamination to occur prior to the product return. It was advised that the reporting customer "washed it in the washing machine" for decontamination. This method was performed due to the end user "feeling sterilization would shrink the catheter". The product was not returned to the qc complaint specialist for eval. Additional info was requested in ref. To the end user's usage of the device and if the ifu contained within the finished good was being followed at the time of the occurrence. The below correspondence was sent to the reporting customer. "ifu 74-14903g rev 3/11 is contained within 81-080412 and has specific instructions in relation to the inflation and deflation of the balloon. Can you please identify if these instructions were followed and if info is available in ref to the usage? Was the product tested prior to insertion as stated in directions for use. Make sure that the catheter is draining properly before inserting the balloon? What type of solution and how much was utilized to inflate the balloon? To inflate the balloon, insert a luer tip syringe filled with the recommended amount of sterile water in the valve (i. E. 3cc or 5cc). Was the valve arm severed in an effort to deflate the balloon as stated in section #11, "if balloon does not collapse after attempting to perform #10, sever the valve arm. If balloon still does not deflate, call physician". No testing of the product was identified as occurring prior to usage. The solution and the amount used. Never identified by the end user. No evidence is present indicating the end user severed the valve arm in an effort to fully drain the balloon. Due to the sample not being returned for eval, testing was conducted on product available in deroyal inventory in an effort to duplicate the reported issue. The product was subjected to functional testing of inflating and deflating the balloon. Testing methods included the use of the foley catheter 12fr and a syringe filed with 10ml of 0. 9% sodium chloride injection, usp. All of the tested unit balloons inflated and deflated as intended. No issues found. Refer to call (b)(6) photos of testing attachment. The qfi report was reviewed for sales and similar complaint info. Deroyal has sold (b)(4) cases/(b)(4) each of the finished good from (b)(6). There have been no previous reports of this nature received for the finished good. This equates to a complaint-to-sales ratio of (b)(4)deroyal will continue to track and trend for this type of report and will recognize in the future if the issue transitions from an isolated event to reoccurring issue. Correction: a correction has not been taken. Root cause analysis: the reported issue has been determined to be an isolated event for the finished good due to the undetermined root cause. The actual sample in which the issue occurred was not returned to the qc complaint specialist due to the contaminated status. Potential root causes have been identified, but are not limited to, the following: vendor related issue with the mfg of the catheter due to the lumen not being fully formed; valve failure; or end user error in not adhering to the ifu and severing the valve arm to attempt to fully drain the balloon. Corrective action and/or systemic correction action taken: ifu 74-14903g has been updated and a precaution added to state, "prior to insertion, test the balloon inflation and deflation. The balloon should be fully deflated before insertion. Follow the recommended balloon inflation volume printed on the product and use sterile water for inflation". The revision date of the ifu is august 2015. Refer to the 74-14903 foley catheter ifu attachment. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2320762-2015-00017 |
| MDR Report Key | 4961819 |
| Report Source | 06 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-29 |
| Date of Event | 2015-06-03 |
| Date Facility Aware | 2015-06-03 |
| Report Date | 2015-07-29 |
| Date Mfgr Received | 2015-06-30 |
| Date Added to Maude | 2015-08-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOLEY CATHETER WITH TEMPERATURE SENSOR |
| Generic Name | CATHETER, UPPER URINARY TRACT |
| Product Code | EYC |
| Date Received | 2015-07-31 |
| Catalog Number | 81-080412 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1595 HIGHWAY 33 SOUTH NEW TAZEWELL TN 37825 US 37825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |