1917413-2016-00018
Report
- Report Number
- 1917413-2016-00018
- Event Type
- Death
- Date Received
- December 22, 2016
- Date of Event
- November 29, 2016
- Report Date
- December 9, 2016
- PMA / PMN Number
- K945952
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
SEE MFG REPORT # 1917413-2016-00019 FOR THE MDR FOR THE REPORTED CATALOG 367844 REFERENCED IN THE EVENT DESCRIPTION. MEDICAL DEVICE BRAND NAME: 13 X 75 MM X 4.0 ML BD VACUTAINER® PLUS PLASTIC PLASMA TUBE WITH GREEN BD HEMOGARD¿ CLOSURE. ADDITIVE: LITHIUM HEPARIN (SPRAY DRIED), 75 USP UNITS. (B)(4). DEVICE EVALUATION: THE FOLLOWING SAMPLES WERE TESTED FROM THE BD VACUTAINER® LITHIUM HEPARIN TUBE (CATALOG NUMBER 367884, LOT NUMBER 6090993): (B)(4) SAMPLES OF THE INCIDENT LOT NUMBER WERE RECEIVED FROM BD (B)(4) DISTRIBUTION AND WERE TESTED FOR DRAW VOLUME AT BD (B)(4) LOCATION IN (B)(4). WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.68 ML ¿ 3.98 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. (B)(4) SAMPLES FROM THE INCIDENT LOT NUMBER WERE RECEIVED FROM THE CUSTOMER FACILITY IN (B)(4) AND WERE TESTED FOR DRAW VOLUME AT BD, (B)(4), USA. WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.85 ML ¿ 3.95 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. (B)(4) SAMPLES FROM THE INCIDENT LOT NUMBER WERE RECEIVED FROM BD PAS MANUFACTURING RETENTION INVENTORY ((B)(4), USA) AND WERE TESTED FOR DRAW VOLUME AT BD (B)(4), USA. WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.90 ML ¿ 4.01 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. (B)(4) FROM THE INCIDENT LOT NUMBER WERE SELECTED FROM BD PAS MANUFACTURING RETENTION INVENTORY ((B)(4), USA) AND WERE TESTED AT THE SAME LOCATION FOR DRAW VOLUME. WE OBSERVED DRAW VOLUMES THAT RANGED FROM 3.81 ML ¿ 4.06 ML, WHICH IS WITHIN THE SPECIFICATION RANGE FOR THESE TUBES, 3.24 ¿ 4.40 ML. FOR THE ABOVE NOTED TESTING, WE DID NOT OBSERVE TUBE PUSH-OFF FROM THE NEEDLE AND/OR AIR BEING INTRODUCED INTO THE COLLECTION LINE. A REVIEW OF THE MANUFACTURING RECORDS ASSOCIATED WITH INCIDENT LOT NUMBER 6090993 WAS PERFORMED, AND WE FOUND NO RELATED QUALITY NOTIFICATIONS ISSUED DURING MANUFACTURING OF THIS LOT. FURTHERMORE, WE HAVE NOT RECEIVED ANY ADDITIONAL CUSTOMER REPORTS OF POSITIVE PRESSURE RELATED INCIDENTS ASSOCIATED WITH THIS LOT. LASTLY, WE CONDUCTED A THOROUGH REVIEW OF THE MANUFACTURING PROCESS FOR THE INCIDENT PRODUCT AND DETERMINED THAT DUE TO THE AUTOMATED EVACUATION SYSTEM THAT WE HAVE IN PLACE WHICH IS CLOSELY MONITORED THERE WERE NO OPPORTUNITIES FOUND WHEREUPON TUBES WITHIN THE EVACUATOR COULD HAVE BEEN POSITIVELY PRESSURIZED. ADDITIONALLY, THERE WERE NO OPPORTUNITIES FOUND WITHIN THE AUTOMATED EVACUATION SYSTEM WHERE A TUBE COULD BE ASSEMBLED WITH A STOPPER WITHOUT THE PRESENCE OF VACUUM. CONCLUSION - BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETENTION SAMPLES. ADDITIONALLY, THE CUSTOMER RETURNED ONE BLOOD COLLECTION SET THAT WAS NOT MANUFACTURED BY BD NOR THE ACTUAL ONE USED IN THE COMPLAINT. NO INVESTIGATION WAS PERFORMED ON THIS DEVICE.
IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED (B)(6) 2016 FOR CORONARY HEART DISEASE AND MULTIVESSEL DISEASE. HIS HEALTH WAS NOTED TO BE IN POOR CONDITION WHEN ADMITTED. ON (B)(6) 2016 THE PATIENT WAS HAVING HIS BLOOD DRAWN AT THE FIRST AFFILIATED HOSPITAL OF (B)(6) UNIVERSITY IN THE DEPARTMENT OF PHYSIOLOGICAL PACING ECG. THE NURSE WAS USING A NON-BD SINGLE WING NEEDLE WITHOUT A HOLDER. THE NURSE PERFORMED THE BLOOD DRAW FROM THE PATIENT¿S RIGHT HAND WITH THE BD VACUTAINER® PLUS PLASTIC PLASMA TUBE (CAT 367884) AND "POSITIVE PRESSURE HAPPENED" WITH THE FIRST ATTEMPT, "PUSHING AIR INTO THE PATIENT'S VESSEL", RESULTING IN A "BULGE PHENOMENON" OR BUMP. THE HEAD NURSE THEN PERFORMED A BLOOD DRAW WITH THE BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE (CAT 367844) ON PATIENT¿S LEFT FOOT BUT THE SAME ISSUE WAS OBSERVED. FINALLY THE HEAD NURSE PERFORMED A THIRD BLOOD DRAW TO THE PATIENT'S RIGHT ARM WITH 2 ADDITIONAL TUBES, CAT 367884. THE FIRST TIME TUBE WAS DRAWN WITHOUT ISSUE BUT THE SECOND TUBE WAS ALSO NOTED TO HAVE THE "PROBLEM OF POSITIVE PRESSURE". THE BUMP THAT HAD APPEARED WHERE THE BLOOD DRAW HAD BEEN PERFORMED "DISAPPEARED BY THE HELP OF (THE) NURSE". THE PATIENT WAS REPORTED TO HAVE PASSED AWAY ON THE NIGHT OF (B)(6) 2016 DUE TO HEART FAILURE.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Death |