TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC
Report
- Report Number
- 1820334-2021-00309
- Event Type
- Injury
- Date Received
- February 11, 2021
- Date of Event
- January 18, 2021
- Report Date
- June 15, 2021
- Manufacturer
- COOK INC
- Product Code
- LJS
- UDI-DI
- 10827002345192
- PMA / PMN Number
- K132334
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION-EVALUATION: IT WAS REPORTED BY HENAN YIJIANYUAN TRADING CO. LTD., A DISTRIBUTOR IN CHINA THAT A TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC (RPN: UPICS-4.0-CT-NT-1111, LOT NUMBER 10292126) SEPARATED. THE PATIENT WAS A 62 YEAR-OLD FEMALE WHO WEIGHED 50 KGS WITH NORMAL ACTIVITY LEVEL. SHE HAD A DIAGNOSIS OF BREAST CANCER. THE PATIENT REQUIRED THE DEVICE FOR THE INFUSION OF MEDICATION TO TREAT BREAST CANCER AND WAS PLACED IN THE PATIENT¿S MIDDLE LEFT UPPER ARM ON (B)(6) 2020 USING ULTRASOUND GUIDANCE. IT HAD A ¿CLAVER¿S¿ SINGLE-CAVITY CONNECTOR MC100¿ CONNECTED TO THE PURPLE HUB. THE DEVICE WAS REPORTED TO HAVE BEEN SECURED TO THE PATIENT USING ¿WATERPROOF AND TRANSPARENT PASTE WITH SIZE 10*12 CM¿ AND WAS ¿FIXED IN A U SHAPE¿. AT THE END OF EACH INFUSION, THE PHYSICIAN USED A ¿PREFILLED CATHETER IRRIGATOR¿ (NORMAL SALINE) FOR PULSE FLUSHING AND POSITIVE PRESSURE SEALING OF THE CATHETER. DURING THE INTERVAL OF TREATMENT, THE PATIENT WENT TO A QUALIFIED HOSPITAL FOR MAINTENANCE. IT WAS REPORTED THAT SALINE WAS USED ONCE OR TWICE PER WEEK FOR MAINTENANCE. THERE WAS NO REPORTED DIFFICULTY ATTACHING OR DISCONNECTING ANCILLARY DEVICES. WHEN THE SEPARATION WAS DISCOVERED DURING THE INFUSION OF MEDICATION, THE DEVICE WAS REMOVED AND REPLACED. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION OF THE RETURNED DEVICE, WAS CONDUCTED DURING THE INVESTIGATION. ONE TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC WAS RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, THE DEVICE WAS NOTED TO BE IN TWO SEGMENTS INCLUDING THE PURPLE HUB AND THE CLEAR TUBING WITH MANIFOLD. BIOMATTER WAS NOTED THROUGHOUT THE DEVICE. THE CLEAR TUBING WAS COMPLETELY SEVERED FROM THE PURPLE HUB. A PHOTO OF THE DEVICE ALSO DEPICTED THE EXTENSION TUBING SEPARATING FROM THE PURPLE HUB. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT (10292126) AND THE RELATED PICC COMPONENT LOT REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH DID NOT IDENTIFY ANY OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. AS THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE SET WAS SUPPLIED WITH IFU (B)(4), WHICH INCLUDES THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: ¿INTENDED USE: THE MAXIMUM PRESSURE LIMIT SETTING FOR POWER INJECTORS USED WITH THE TURBO-JECT PICC MAY NOT EXCEED 325 PSI AND THE FLOW RATE MAY NOT EXCEED THE MAXIMUM FLOW RATE INDICATED. WARNINGS: THE SAFE AND EFFECTIVE USE OF TURBO-JECT PICC LINES WITH POWER INJECTOR PRESSURES SET ABOVE 325 PSI 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. 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 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, INSPECTION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE FOR THIS EVENT WAS UNABLE TO BE ESTABLISHED. IT WAS REPORTED THAT THE DEVICE WAS "FIXED IN A U SHAPE" UNDER A DRESSING. NOT ALLOWING THE EXTENSION TUBING AND HUBS TO REMAIN OUTSIDE OF THE BANDAGE AND PLACING IT IN THIS CONFIGURATION CAN APPLY ADDITIONAL PRESSURE ON THE CONNECTIONS. ADDITIONALLY, PERFORMING ACTIVITIES OF DAILY LIVING (ADLS) MAY HAVE PROVIDED AN OPPORTUNITY FOR INADVERTENT TENSION TO BE PLACED ON THE DEVICE, ESPECIALLY SINCE THE PATIENT WAS REPORTED TO BE ACTIVE. APPROPRIATE MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. A CAPA IS CURRENTLY IN PROGRESS TO FURTHER INVESTIGATE THIS FAILURE MODE IN RELATION TO THIS DEVICE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. 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.
H6- HEALTH EFF IMPACT CODE GRID. 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.
ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT WAS RECEIVED ON 24FEB2021. THE PATIENT WAS DESCRIBED TO HAVE A "NORMAL" ACTIVITY LEVEL. THE DEVICE WAS PLACED FOR INFUSION OF MEDICATION FOR THE PATIENT'S BREAST CANCER. THERE WAS NO REPORTED DIFFICULTY ATTACHING OR DISCONNECTING ANCILLARY DEVICES TO THE DEVICE. A COMPETITOR DEVICE WAS CONNECTED TO THE END OF THE CATHETER. DURING HOSPITALIZATION, AT THE END OF EACH CATHETER INFUSION, THE PHYSICIAN USED A PREFILLED CATHETER IRRIGATOR (NORMAL SALINE) FOR PULSE FLUSHING AND POSITIVE PRESSURE SEALING OF THE CATHETER. DURING TREATMENT, THE PATIENT WENT TO A QUALIFIED HOSPITAL FOR MAINTENANCE. SALINE WAS USED ONE-TWO TIMES A WEEK DURING MAINTENANCE. THE DEVICE WAS SECURED TO THE PATIENT "ACCORDING TO THE MAINTENANCE REQUIREMENTS OF THE CATHETER DURING THE USE OF THE CATHETER, WATERPROOF AND TRANSPARENT PASTE WITH SIZE 10*12CM" AND WAS FIXED IN A "U SHAPE". AS A RESULT OF THE DEVICE FAILURE, IT WAS REMOVED AND REPLACED.
INITIAL REPORTER: (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 POWER-INJECTABLE PICC SEPARATED AT THE JUNCTION OF THE EXTENSION TUBING AND HUB APPROXIMATELY TWO MONTHS AFTER USE. DURING INFUSION, THE EXTENSION TUBE WAS REPORTED TO HAVE RUPTURED, RESULTING IN LEAKAGE. THE NURSE WITHDREW THE CATHETER IMMEDIATELY. IT WAS ALSO REPORTED THAT "ULTRASOUND-GUIDED PICC CATHETERIZATION WAS PERFORMED IN THE MIDDLE LEFT UPPER ARM OF THE PATIENT". NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 211110 | TURBO-JECT SINGLE LUMEN POWER-INJECTABLE PICC | LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | LJS | COOK INC | 10292126 | 10827002345192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | CLAVER¿S SINGLE-CAVITY CONNECTOR MC100 |