3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 5 ML SYRINGE
Report
- Report Number
- 2243072-2018-00221
- Event Type
- Malfunction
- Date Received
- April 26, 2018
- Date of Event
- February 10, 2018
- Report Date
- August 6, 2018
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FOZ
- PMA / PMN Number
- K011982
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
H.6. INVESTIGATION SUMMARY: LOT: 722311B THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATIONS RELATED TO THE MANUFACTURE OF LOT 722311B OR RAW MATERIALS USED TO MANUFACTURE THIS LOT. PRIOR TO THE REPORT OF INFECTION EVALUATED FOR MPS-18-1248-SA, THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. UPON REVIEWING THE PRODUCTION HISTORY FOR THE PROVIDED LOT NUMBER, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN APRIL 2018, CAPA (B)(4) WAS INITIATED TO ADDRESS THIS ISSUE. 100% OF THE RETAINED SAMPLES FOR THE LOT (120 UNITS) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., SOLUTION WAS CLEAR). 40 UNITS OF THE RETAINED SAMPLES WERE SENT TO NELSON LABORATORIES, INC. FOR STERILITY TESTING IN MAY 218. THE STERILITY TESTING WAS PERFORMED IN AN ISOLATOR PER USP 71 MEMBRANE FILTRATION METHOD. PER THE ATTACHED LAB REPORT (1050356-S01), AFTER INCUBATION, THE RETAINED SAMPLES EXHIBITED NO MICROBIAL GROWTH. INVESTIGATION CONCLUSION: THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER CAPA (B)(4)HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT.
ON 5/3/2018, THE DEVICE CATALOG AND LOT NUMBERS WERE PROVIDED. ADDITIONAL DETAILS FOR THE INCIDENT WERE ALSO PROVIDED. THE UPDATED INFORMATION IS AS FOLLOWS: PATIENT IDENTIFIER: (B)(6), AGE AT TIME OF EVENT: (B)(6), SEX: FEMALE. DATE OF EVENT: (B)(6) 2018. EVENT ATTRIBUTED TO: REQUIRED INTERVENTION. DESCRIBE EVENT OR PROBLEM: (ADDITIONAL INFORMATION) THE PATIENT INVOLVED WAS A (B)(6) OLD FEMALE PICU PATIENT WITH FEMORAL CVC, UROSEPSIS, TRACHEAL ASPIRATE (+) FOR SERRATIA MARCESCENS AND S. AUREUS ON (B)(6) 2018. THE 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 5 ML SYRINGE WERE USED FOR IV FLUSHES AS WELL AS IRRIGATION AND SUCTIONING OF THE ENDOTRACHEAL TUBE. RELEVANT TESTS/LABORATORY DATA: BLOOD CULTURES. OTHER RELEVANT HISTORY: 1 MONTH OLD FEMALE PICU PATIENT WITH FEMORAL CVC, UROSEPSIS, TRACHEAL ASPIRATE (+) FOR SERRATIA MARCESCENS AND S. AUREUS ON (B)(6) 2018. MEDICAL DEVICE BRAND NAME: 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 5 ML SYRINGE, MEDICAL DEVICE TYPE: FOZ (CORRECTED FROM NGT). MEDICAL DEVICE MANUFACTURER: (B)(4), MEDICAL DEVICE CATALOG #: 306505, MEDICAL DEVICE LOT #: 722311B, MEDICAL DEVICE EXPIRATION DATE: 8/10/2020, UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: (B)(4), PMA / 510(K)#: K011982. DEVICE MANUFACTURE DATE: 8/14/2017.
INVESTIGATION SUMMARY: LOT: 722311B. THERE WERE NO DEVIATIONS, NON-CONFORMANCES, OR OUT OF SPECIFICATIONS RELATED TO THE MANUFACTURE OF LOT 722311B OR RAW MATERIALS USED TO MANUFACTURE THIS LOT. PRIOR TO THE REPORT OF INFECTION EVALUATED FOR (B)(4), THERE WAS NO TREND FOR INFECTION CASES REPORTED FOR FRANKLIN PRODUCT. UPON REVIEWING THE PRODUCTION HISTORY FOR THE PROVIDED LOT NUMBER, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE COMPLAINT IS PART OF A NEW TREND WHICH BEGAN IN (B)(6) 2018, (120 UNITS) WAS INITIATED TO ADDRESS THIS ISSUE. 100% OF THE RETAINED SAMPLES FOR THE LOT (B)(4) WERE VISUALLY INSPECTED. NO GROWTH WAS SEEN (I.E., SOLUTION WAS CLEAR). 40 UNITS OF THE RETAINED SAMPLES WERE SENT TO NELSON LABORATORIES, INC. FOR STERILITY TESTING IN (B)(6) 2018. THE STERILITY TESTING WAS PERFORMED IN AN ISOLATOR PER USP 71 MEMBRANE FILTRATION METHOD. PER THE ATTACHED LAB REPORT (B)(4), AFTER INCUBATION, THE RETAINED SAMPLES EXHIBITED NO MICROBIAL GROWTH. INVESTIGATION CONCLUSION: THE ROOT CAUSE ANALYSIS OF THE REPORTED INFECTION CASES UNDER (B)(4) HAS NOT IDENTIFIED A DIRECT CAUSATION BETWEEN THE INFECTIONS AND THE BD FRANKLIN PRODUCT.
IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION.
(ADDITIONAL INFORMATION) THE PATIENT INVOLVED WAS A (B)(6) OLD FEMALE PICU PATIENT WITH FEMORAL CVC, UROSEPSIS, TRACHEAL ASPIRATE (+) FOR SERRATIA MARCESCENS AND S. AUREUS ON (B)(6) 2018. THE 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 5 ML SYRINGE WERE USED FOR IV FLUSHES AS WELL AS IRRIGATION AND SUCTIONING OF THE ENDOTRACHEAL TUBE.
IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF AN UNSPECIFIED BD POSIFLUSH NORMAL SALINE SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION.
A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
CORRECTIONS: EVENT DESCRIPTION: THE STATEMENT, "THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION," SHOULD NOT HAVE BEEN USED IN THE EVENT DESCRIPTION. CORRECTING TO STATE: IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. TYPE OF REPORT: THE INITIAL MDR WAS SUBMITTED AS A 30-DAY REPORT. BD HAS CHANGED OUR POSITION ON THIS INCIDENT AND WE ARE MAKING A CORRECTION TO REPORT THE MDR AS A 5-DAY REPORT. TYPE OF REPORTABLE EVENTS: SHOULD NOT HAVE BEEN LISTED AS "MALFUNCTION". CORRECTING TO INDICATE "SERIOUS INJURY".
IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT INFECTIONS ASSOCIATED WITH CENTRAL LINES AND THE USE OF AN UNSPECIFIED BD POSIFLUSH¿ NORMAL SALINE SYRINGE WERE BEING INVESTIGATED BY THE FDA. THERE WAS NO EVIDENCE THAT THE BD DEVICE IS IMPLICATED BUT ALL SOURCES AND COMMON PRODUCTS ARE BEING INVESTIGATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309913 | 3 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 5 ML SYRINGE | PREFILLED SALINE FLUSH SYRINGE | FOZ | BECTON DICKINSON MEDICAL SYSTEMS | 722311B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Other| R |