SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
Report
- Report Number
- 1820334-2016-01428
- Event Type
- Injury
- Date Received
- December 7, 2016
- Report Date
- November 27, 2018
- Manufacturer
- COOK INC
- Product Code
- FOZ
- PMA / PMN Number
- K950118
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- PHYSICIAN
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, TRENDS, AS WELL AS A FUNCTIONAL TEST, VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED LIKE DEVICES WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED, HOWEVER FIFTY-SIX UNOPENED SETS CONSISTING OF THREE LOT NUMBERS; NS6813297 (QTY 20), NS6813301 (QTY 19) AND NS6813298 (QTY 17) WERE RETURNED FOR INVESTIGATION. FOR EACH LOT EXAMINED, FUNCTIONAL TESTS NOTED THAT THE WIRE GUIDES AND STYLETS WERE TOO SHORT TO PASS THROUGH THE CATHETER. ALL CATHETERS WERE ABLE TO BE FLUSHED WITH WATER. A LEAK TEST WAS PERFORMED AND WAS UNABLE TO CONFIRM THE PRESENCE OF A LEAK OR RUPTURE IN THE MATERIALS OF THE CATHETERS. THE PHYSICAL INVESTIGATION TESTED FOR AS MANY FAILURES AS POSSIBLE ON ALL RETURNED DEVICES AND NO FAILURES WERE IDENTIFIED. DIMENSIONAL ANALYSIS CONFIRMED THAT ALL DEVICES WERE MANUFACTURED TO THE CORRECT SPECIFICATIONS AND TOLERANCES. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY AND FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THESE LOT NUMBERS. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF LIKE PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.
NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.
A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, INSTRUCTIONS FOR USE (IFU), TRENDS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBE: CATHETER TIP POSITIONING SECTION: "VERIFY CATHETER TIP POSITION USING RADIOGRAPHY OR APPROPRIATE TECHNOLOGY. IN ORDER TO GUARANTEE EXTRA PERICARDIAL LOCATION, THE CATHETER TIP SHOULD BE LOCATED ABOVE THE SVC-RA JUNCTION, WITHIN THE LOWER 1/3 OF THE SVC. EVERY EFFORT MUST BE MADE TO ASCERTAIN PROPER TIP POSITION IN ORDER TO PREVENT EROSION OR PERFORATION OF THE CENTRAL VENOUS SYSTEM AND TO ENSURE PROPER DELIVERY OF INFUSATES.¿ CATHETER MAINTENANCE SECTION: "HEPARIN 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 WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE. LUMEN SHOULD BE FLUSHED WITH NORMAL SALINE BETWEEN ADMINISTRATIONS OF DIFFERENT INFUSATES. AFTER USE, LUMEN SHOULD AGAIN BE FLUSHED WITH TWICE THE INDICATED LUMEN VOLUME USING NORMAL SALINE BEFORE REESTABLISHING HEPARIN LOCK." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND RESULTS OF THE INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.
IT WAS REPORTED THAT AFTER INSERTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, IT WAS DISCOVERED THERE WAS OOZING FROM THE PUNCTURE SITE. ANOTHER DEVICE WAS USED TO REPLACE THIS ONE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE . REPEAT PICC LINE PLACEMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
IT WAS REPORTED THAT AFTER INSERTION OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, IT AS WAS DISCOVERED THERE WAS OOZING FROM THE PUNCTURE SITE. ANOTHER DEVICE WAS USED TO REPLACE THIS ONE. THE DEVICE WAS PLACED EITHER IN THE RIGHT BASILIC VEIN OR BRACHIAL VEIN. THE TIP WAS PLACED IN THE THIRD PART OF THE SUPERIOR VENA CAVA. AS A RESULT, THE PATIENT REQUIRED ADDITIONAL PROCEDURE TO REPLACE THE PICC LINE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 801815 | SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET | FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | COOK INC | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |