THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M005
Report
- Report Number
- 3005099803-2010-05333
- Event Type
- Injury
- Date Received
- January 3, 2011
- Date of Event
- December 9, 2010
- Report Date
- December 10, 2010
- Manufacturer
- BOSTON SCIENTIFIC - SPENCER
- Product Code
- KNT
- PMA / PMN Number
- K091340
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
A VISUAL EXAMINATION OF THE DEVICE REVEALED THE GUIDEWIRE TO BE IN THE HOOP. THE TIP OF THE GUIDEWIRE WAS FOUND TO BE BROKEN AND BENT AT POINT WHERE IT EXITED THE HOOP. NO OTHER COMPONENTS WERE RETURNED. THE CONDITION OF THE SUBJECT UNIT COULD NOT BE VERIFIED DUE TO THE J-TUBE DEVICE NOT BEING RETURNED. THERE IS NOT ENOUGH INFORMATION PER THE EVENT DESCRIPTION TO PROVIDE A MOST PROBABLE ROOT CAUSE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. ONLY THE DAMAGED GUIDEWIRE WAS RETURNED. THE GUIDEWIRE WAS UN-USED AND THE DAMAGE WAS CONTAINED TO THE GUIDEWIRE TIP AS IT EXITED THE HOOP AND IT APPEARS THE DAMAGE OCCURRED DURING HANDLING. THE MOST PROBABLE ROOT CAUSE FOR THE OBSERVED DAMAGE TO THE GUIDEWIRE IS CONSIDERED HANDLING. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO ISSUES RELATED TO THIS COMPLAINT.
(B)(4):THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE HAVE NOT YET DETERMINED THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MANUFACTURER'S REPORT WILL BE FILED.
NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO COMPLAINTS. REFER TO MANUFACTURER REPORT # 3005099803-2010-05334 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. ACCORDING TO THE COMPLAINANT, ON (B)(6), 2010, A THREE PORT JEJUNAL FEEDING TUBE, PLACED ON (B)(6), 2010, WAS NOTED TO HAVE A TEAR WHERE THE NURSE SAW STOMACH CONTENTS LEAKING FROM THE SIDE OF THE Y-PORT. A SECOND J-TUBE (THE SUBJECT OF THIS REPORT) WAS OPENED AND A TEAR WAS ALSO NOTED TO THE Y-PORT AND NOT USED. THE INITIAL PLACED DEVICE WAS EVENTUALLY REPLACED ON (B)(6), 2010. THERE WAS NO INTERRUPTION IN THE DELIVERY OF NUTRIENTS AND NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2010-05334 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A THREE PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS PLACED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2010, THE NURSE SAW STOMACH CONTENTS LEAKING FOR A TEAR IN THE SIDE OF THE Y-PORT. A NEW THREE PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS OPENED HOWEVER THIS KIT ALSO HAD A TEAR IN THE SIDE OF THE Y-PORT. THIS DEVICE WAS NOT PLACED. UNTIL RECEIPT OF ANOTHER NEW THREE PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE), SURGICAL TAPE HAD BEEN PLACED OVER THE TEAR IN THE ORIGINAL DEVICE AND THE PATIENT WAS ABLE TO RECEIVE NUTRITION THROUGH THE DEVICE. ON (B)(6), 2010 THE PATIENT RECEIVED A NEW THREE PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE). THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M005 | TUBES, GASTROINTESTINAL (AND ACCESSORIES) | KNT | BOSTON SCIENTIFIC - SPENCER | M00566340 | 13747113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |