TURBO-JECT DOUBLE LUMEN POWER-INJECTABLE PICC
Report
- Report Number
- 1820334-2021-00391
- Event Type
- Injury
- Date Received
- February 26, 2021
- Date of Event
- February 18, 2021
- Report Date
- April 26, 2021
- Manufacturer
- COOK INC
- Product Code
- LJS
- UDI-DI
- 10827002239026
- PMA / PMN Number
- K132885
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION ¿ EVALUATION: IT WAS REPORTED BY (B)(4) FROM C.H.R.U. DE CAEN, CAEN, FRANCE THAT THERE WAS A SUSPECTED CRACK IN A PATIENT¿S PICC LINE. THE DEVICE WAS REPORTED TO BE A TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC (RPN: UPICDS-5.0-CT-NT-1111, LOT NUMBER 13324942). THE MALE PATIENT PRESENTED TO ¿HDJ¿ FOR A PLATELET INFUSION ON 18FEB2021. HE WAS RECEIVING PLATELETS, 14G/LITER FOR THROMBOCYTOPENIA TREATMENT. IT WAS REPORTED THAT AT THE END OF THE INFUSION, THE PATIENT¿S ARM BECAME PAINFUL, HOT, AND INFLAMED. IT WAS REPORTED ¿IT SEEMS A PART IS DIFFUSED DIRECTLY INTO HIS ARM¿. THE PHYSICIAN THOUGHT THAT THE PICC LINE MAY HAVE CRACKED AS THIS WAS THE FIRST OCCURRENCE OF THIS EVENT. HOWEVER, THEY WERE UNABLE TO CONFIRM. THE DEVICE WAS REMOVED, AND A NEW PICC LINE WAS PLACED ON 23FEB2021. A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE TURBO-JECT DOUBLE LUMEN POWER-INJECTABLE PICC WAS RETURNED FOR EVALUATION. THE NEEDLELESS CONNECTOR AND GAUZE WERE REMOVED FROM THE HUBS TO ALLOW FOR A FULL INSPECTION OF THE DEVICE. A VISUAL EXAM CONFIRMED A 1 CM SPLIT IN THE CATHETER THAT BEGAN NEAR THE MANIFOLD. NO OTHER DAMAGE WAS FOUND ON THE CATHETER TUBING, EXTENSION TUBING OR HUBS. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOUND THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 13324942 FOUND NO NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THIS LOT NUMBER. BECAUSE 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 THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION RELATED TO THE REPORTED FAILURE MODE: "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 LINES WITH A POWER INJECTOR, THE TECHNICIAN/HEALTH CARE PROFESSION MUST VERIFY: THE CATHETER LUMEN HAS "CT" ON THE HUB TO INDICATE THE LUMEN IS POWER INJECTABLE -PRIOR TO USE THAT THE MAXIMUM PRESSURE LIMIT IS SET AT OR BELOW 325PSI AND THAT THE MAXIMUM FLOW RATE IS AT OR BELOW THAT WHICH IS LIST ON THE CATHETER. DYNAMIC AND STATIC PRESSURE TEST RESULTS ARE SHOWN IN THE FOLLOWING TABLE (PROVIDED IN THE IFU) 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, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE CAUSE CAN BE TRACED TO THE USER AND AN UNINTENDED USER ERROR. COOK WAS UNABLE TO RULE OUT CATHETER MAINTENANCE OR IMPROPER ACCESS OF THE DEVICE AS A CAUSE OF THE EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. WE 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. 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 PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ADDITIONAL INFORMATION WAS PROVIDED ON 01MAR2021. THE PATIENT WAS RECEIVING A PLATELET INFUSION FOR THROMBOCYTOPENIA. IT WAS BEING INFUSED AT 14G/L. THE CUSTOMER IS UNSURE IF THE REPORTED CRACK IN THE PICC LINE REALLY EXISTS. A NEW PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS PLACED ON (B)(6) 2021.
OCCUPATION: UNKNOWN. 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 DOUBLE LUMEN POWER-INJECTABLE PICC LINE CRACKED DURING A PLATELET TRANSFUSION. THE PATIENT CAME TO THE FACILITY FOR A PLATELET TRANSFUSION. AT THE END OF THE INFUSION, THE PATIENT'S ARM BECAME PAINFUL, HOT AND INFLAMED. IT WAS BELIEVED THAT THE INFUSION DIFFUSED DIRECTLY INTO THE ARM OF THE PATIENT. THE LINE WAS REMOVED, AS THE PHYSICIAN BELIEVED THAT THE PICC MAY HAVE BEEN CRACKED. THIS WAS THE FIRST TIME THAT THIS HAD OCCURRED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284978 | TURBO-JECT DOUBLE LUMEN POWER-INJECTABLE PICC | LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER | LJS | COOK INC | N/A | 13324942 | 10827002239026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |