TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
Report
- Report Number
- 1820334-2020-02149
- Event Type
- Malfunction
- Date Received
- November 18, 2020
- Date of Event
- October 23, 2020
- Report Date
- March 1, 2021
- Manufacturer
- COOK INC
- Product Code
- LJS
- UDI-DI
- 10827002558837
- PMA / PMN Number
- K111244
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY E.O.X.I. VGO THAT A PICC LINE HAD A LEAK IN THE BETWEEN THE CONEXION AND THE TUBE OF THE CATHETER. THE PICC LINE WAS INSERTED 1MONTH BEFORE THE EVENT. THE NURSE REALIZED THAT IT WAS A LEAK IN THE CATHETER WHEN THEY ADMINISTRATED MEDICATION WITH A SYRINGE THROUGH THE PICC LINE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. A MARKED UP MARKETING IMAGE WAS PROVIDED INDICATING THAT THE LEAK OCCURRED WHERE THE SINGLE CATHETER TUBING ENTERS THE PURPLE MANIFOLD WITH SUTURE WINGS. IT WAS REPORTED THAT NO COMPLAINT DEVICE WOULD BE RETURNED. A COMPLAINT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE NORTH AMERICA DISTRIBUTION CENTER RECORDS WERE REVIEWED AND THERE WAS NO PRODUCT FROM THE LOT IN STOCK, SO A SAMPLE OF THE SAME LOT COULD NOT BE INSPECTED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO ASSURE DEVICE INTEGRITY AND FUNCTIONALITY PRIOR TO SHIPMENT. IN RESPONSE TO THIS INCIDENT THE DEVICE HISTORY RECORD FOR THE COMPLAINT LOT WAS REVIEWED AND NO RELATED ANOMALIES WERE IDENTIFIED. A DATABASE SEARCH FOUND NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THE COMPLAINT DEVICE LOT. THE EVIDENCE FROM THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY AND QUALITY CONTROL DOCUMENTS INDICATES THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION AS WELL AS OTHER ITEMS IN THE LOT OR SIMILAR DEVICES IN THE FIELD OR IN HOUSE. THE SET WAS SUPPLIED WITH AN IFU WHICH INCLUDES THE FOLLOWING: WARNINGS: -THE SAFE AND EFFECTIVE USE OF TURBO-JECT PICC LINES WITH POWER INJECTOR PRESSURES SET ABOVE 325PSI HAS NOT BEEN ESTABLISHED -DO NOT POWER INJECT IF MAXIMUM INJECTION RATE CANNOT BE VERIFIED TO MEET LIMIT PRINTED ON CATHETER HUB OR EXTENSION TUBE. -TO SAFELY USE TURBO-JECT PICC WITH A POWER INJECTOR, THE TECHNICIAN/HEALTH CARE PROFESSIONAL MUST VERIFY PRIOR TO USE THAT THE MAXIMUM PRESSURE LIMIT IS SET AT OR BELOW 325PSI AND THAT THE MAXIMUM FLOW IS AT OR BELOW THAT WHICH IS LISTED ON THE CATHETER. DYNAMIC AND STATIC PRESSURE TEST RESULTS ARE SHOWN ON THE FOLLOWING TABLE A TABLE IS INCLUDED IN THE TABLE IN IFU WITH DATA THAT INCLUDES UPICS WITH A SIZE 3.0/SINGLE PRECAUTIONS. -IF LUMEN FLOW IS IMPEDED, DO NO FORCE INJECTION OR WITHDRAWAL OF FLUIDS. NOTIFY ATTENDING PHYSICIAN IMMEDIATELY. PRECAUTIONS: IF LUMEN FLOW IS IMPEDED, DO NOT FORCE INJECTION OR WITHDRAWAL OF FLUIDS. NOTIFY ATTENDING PHYSICIAN IMMEDIATELY. CATHETER MAINTENANCE: ¿.IF CATHETER IS NOT TO BE USED IMMEDIATELY, ITS LUMEN SHOULD BE MAINTAINED BY CONTINUOUS SALINE OR HEPARINIZED SALINE DRIP OR LOCKED WITH A CATHETER LOCKING SOLUTION. NOTE: IF CLC-2000, MICROCLAVE OR OTHER NEEDLESS ADAPTERS APPROVED FOR SALINE ONLY LOCK ARE USED, SALINE ONLY CATHETER LOCK MAY BE USED. CATHETER HEPARINIZATION SHOULD BE DETERMINED BY INSTITUTIONAL PROTOCOL AND CLINICAL JUDGEMENT. HEPARIN CONCENTRATIONS OF 10 UNITS/ML TO 100 UNITS/ML HAVE BEEN REPORTED ADEQUATE TO MAINTAIN LUMEN PATENCY. CATHETER LOCK SHOULD BE REESTABLISHED AFTER EVERY USE OR AT LEAST EVERY 24 HOURS IF UNUSED. BEFORE USING CATHETER LUMEN ALREADY LOCKED WITH HEPARIN, LUMEN SHOULD BE FLUSHED TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE. LUMEN SHOULD BE FLUSHED WITH NORMAL SALINE BETWEEN ADMINISTRATION OF DIFFERENT INFUSATES. AFTER USE, LUMEN SHOULD BE AGAIN BE FLUSHED WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE BEFORE REESTABLISHING CATHETER LOCK. STRICT ASEPTIC TECHNIQUE MUST BE ADHERED TO WHILE USING AND MAINTAINING CATHETER. BASED ON THE INFORMATION PROVIDED, NO INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
IN ADDITIONAL INFORMATION RECEIVED ON 22DEC2020, IT WAS REPORTED THAT THE INDICATION FOR DEVICE PLACEMENT WAS FOR ONCOLOGIC TREATMENT. THE DEVICE WAS REMOVED AS A RESULT OF THE LEAKING.
CUSTOMER (PERSON): PHONE: (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED THAT A TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WAS LEAKING BETWEEN THE HUB AND THE TUBING. THE DEVICE WAS IMPLANTED IN A (B)(6) FEMALE PATIENT 1 MONTH BEFORE THE EVENT OCCURRED. THE LEAK WAS NOTICED WHEN THE NURSE WAS ADMINISTERING MEDICATION THROUGH THE PICC LINE WITH A SYRINGE. THE LEAK OCCURRED AT THE POINT "BETWEEN THE CONNECTION AND THE TUBE OF THE CATHETER". NO ADVERSE EFFECTS HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING PATIENT/EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1329360 | TURBO-JECT SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | LJS | COOK INC | 13306032 | 10827002558837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | INFUSION LINE| SYRINGE |