BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Report
- Report Number
- 2243072-2019-02488
- Event Type
- Injury
- Date Received
- November 6, 2019
- Date of Event
- October 17, 2019
- Report Date
- December 16, 2019
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- K110443
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE CHANGE IS AS FOLLOWS: DATE OF EVENT: (B)(6) 2019.
THE CHANGES ARE AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9170536. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. H.4. DEVICE MANUFACTURE DATE: 2019-06-19. D.1. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. D. 1 MEDICAL DEVICE TYPE: FOZ. D.2. COMMON DEVICE NAME: INTERVASCULAR CATHETER. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D.4 MEDICAL DEVICE CATALOG #: 382534. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2 MANUFACTURING LOCATION:BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA / 510(K)#: K110443. H3 OTHER TEXT : SEE. H.10.
INVESTIGATION SUMMARY: ONE PHOTO WAS SUBMITTED FOR EVALUATION. THE PHOTO DISPLAYED A SAFETY BARREL ASSEMBLY WITH THE NEEDLE RETRACTED INSIDE. THE UNIT WAS TAPED TO A YELLOW PIECE OF PAPER, WITH A BLACK ARROW POINTING TO THE TOP OF THE GRIP. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. PHOTO EVALUATION : THE PHOTO DISPLAYED THE BLACK ARROW POINTING TO THE FLANGE ON THE WHITE BUTTON. THE FLANGE IS A PART OF THE BUTTON AND DOES SLIGHT STICK UP. ¿FROM THE CUSTOMER VERBATIM : BASICALLY, THE PLASTIC RETRACTION SHEATH RETRACTS SO FAR THAT A TINY, VERY SHARP PIECE IS LEFT STICKING UP.¿ THIS IS A STANDARD OUTCOME WHEN THE NEEDLE IS RETRACTED. THAT IS IN THE CORRECT POSITION FOR THE FLANGE ON THE WHITE BUTTON. CONCLUSION(S): BASED ON THE EVALUATION OF THE SUBMITTED PHOTO; THE DEFECT CATHETER DEFECTIVE/DAMAGE COULD NOT BE REFUTED NOR CONFIRMED.
IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH AN UNSPECIFIED BD IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED 2 NURSES WERE CUT ON THE PLASTIC PART OF THE CATHETER. THERE IS A VERY SMALL PIECE OF PLASTIC THAT IS LEFT EXPOSED WHEN THE CATHETER FULL RETRACTS THEN STICKS OUT JUST SLIGHTLY. WHEN IT DOES THIS, IT BRINGS WITH IT A LITTLE OF THE PATIENTS BLOOD. ON FRIDAY, ONCE OF MY ACE IV START PERSONNEL <WHO HAPPENS TO ALSO BE PREGNANT AT THIS TIME> WAS CUT BY THE PLASTIC PIECE THAT HAD SOME OF THE PATIENTS BLOOD ON IT. I WAS TOLD THAT A SIMILAR THING HAPPENED TO AN L&D NURSE AS WELL. YOU CAN SEE FROM A VERY CLOSE INSPECTION OF THE PIC THAT TINY PLASTIC PIECE THAT STICKS OUT. HELLO JUST AN UPDATE.... SHE (MOTHER-TO-BE) WAS STUCK BY THE PLASTIC PIECE WHICH JETS OUT ON TOP OF THE IV CATH. I AM TAPING IT TO A PIECE OF PAPER AND STICKING IT IN YOUR MAILBOX. SHE WAS USING THE CATH CORRECTLY, NO VARIANCES. UNFORTUNATELY, IT DID DRAW BLOOD AND SHE HAD TO GO TO EMP HEALTH. DURING HER VISIT, SHE WAS TOLD BY EMP HEALTH STAFF THAT SOMEONE ELSE FROM THE FLOOR HAD ALSO BEEN STUCK IN THE SAME FASHION. SO...2 RNS STUCK BY THESE IV CATHS!!! BASICALLY, THE PLASTIC RETRACTION SHEATH RETRACTS SO FAR THAT A TINY, VERY SHARP PIECE IS LEFT STICKING UP. PERHAPS THIS IS INFORMATION THAT CAN BE SHARED? AT THIS TIME, THERE HAS BEEN NO IV REPS SEEN OR HEARD FROM. " 1 OF 2 COMPLAINTS.
IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH AN UNSPECIFIED BD IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED 2 NURSES WERE CUT ON THE PLASTIC PART OF THE CATHETER. THERE IS A VERY SMALL PIECE OF PLASTIC THAT IS LEFT EXPOSED WHEN THE CATHETER FULL RETRACTS THEN STICKS OUT JUST SLIGHTLY. WHEN IT DOES THIS, IT BRINGS WITH IT A LITTLE OF THE PATIENTS BLOOD. ON FRIDAY, ONCE OF MY ACE IV START PERSONNEL WHO HAPPENS TO ALSO BE PREGNANT AT THIS TIME> WAS CUT BY THE PLASTIC PIECE THAT HAD SOME OF THE PATIENTS BLOOD ON IT. I WAS TOLD THAT A SIMILAR THING HAPPENED TO AN L&D NURSE AS WELL. YOU CAN SEE FROM A VERY CLOSE INSPECTION OF THE PIC THAT TINY PLASTIC PIECE THAT STICKS OUT. HELLO JUST AN UPDATE.... SHE (MOTHER-TO-BE) WAS STUCK BY THE PLASTIC PIECE WHICH JETS OUT ON TOP OF THE IV CATH. I AM TAPING IT TO A PIECE OF PAPER AND STICKING IT IN YOUR MAILBOX. SHE WAS USING THE CATH CORRECTLY, NO VARIANCES. UNFORTUNATELY, IT DID DRAW BLOOD AND SHE HAD TO GO TO EMP HEALTH. DURING HER VISIT, SHE WAS TOLD BY EMP HEALTH STAFF THAT SOMEONE ELSE FROM THE FLOOR HAD ALSO BEEN STUCK IN THE SAME FASHION. SO...2 RNS STUCK BY THESE IV CATHS!!! BASICALLY, THE PLASTIC RETRACTION SHEATH RETRACTS SO FAR THAT A TINY, VERY SHARP PIECE IS LEFT STICKING UP. PERHAPS THIS IS INFORMATION THAT CAN BE SHARED? AT THIS TIME, THERE HAS BEEN NO IV REPS SEEN OR HEARD FROM. " 1 OF 2 COMPLAINTS.
IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH AN UNSPECIFIED BD IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED 2 NURSES WERE CUT ON THE PLASTIC PART OF THE CATHETER. THERE IS A VERY SMALL PIECE OF PLASTIC THAT IS LEFT EXPOSED WHEN THE CATHETER FULL RETRACTS THEN STICKS OUT JUST SLIGHTLY. WHEN IT DOES THIS, IT BRINGS WITH IT A LITTLE OF THE PATIENTS BLOOD. ON FRIDAY, ONCE OF MY ACE IV START PERSONNEL <WHO HAPPENS TO ALSO BE PREGNANT AT THIS TIME> WAS CUT BY THE PLASTIC PIECE THAT HAD SOME OF THE PATIENTS BLOOD ON IT. I WAS TOLD THAT A SIMILAR THING HAPPENED TO AN L&D NURSE AS WELL. YOU CAN SEE FROM A VERY CLOSE INSPECTION OF THE PIC THAT TINY PLASTIC PIECE THAT STICKS OUT. "HELLO JUST AN UPDATE.... SHE (MOTHER-TO-BE) WAS STUCK BY THE PLASTIC PIECE WHICH JETS OUT ON TOP OF THE IV CATH. I AM TAPING IT TO A PIECE OF PAPER AND STICKING IT IN YOUR MAILBOX. SHE WAS USING THE CATH CORRECTLY, NO VARIANCES. UNFORTUNATELY, IT DID DRAW BLOOD AND SHE HAD TO GO TO EMP HEALTH. DURING HER VISIT, SHE WAS TOLD BY EMP HEALTH STAFF THAT SOMEONE ELSE FROM THE FLOOR HAD ALSO BEEN STUCK IN THE SAME FASHION. SO...2 RNS STUCK BY THESE IV CATHS!!! BASICALLY, THE PLASTIC RETRACTION SHEATH RETRACTS SO FAR THAT A TINY, VERY SHARP PIECE IS LEFT STICKING UP. PERHAPS THIS IS INFORMATION THAT CAN BE SHARED? AT THIS TIME, THERE HAS BEEN NO IV REPS SEEN OR HEARD FROM. " 1 OF 2 COMPLAINTS.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG OR A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT, AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT A SERIOUS INJURY OCCURRED WITH AN UNSPECIFIED BD IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED 2 NURSES WERE CUT ON THE PLASTIC PART OF THE CATHETER. THERE IS A VERY SMALL PIECE OF PLASTIC THAT IS LEFT EXPOSED WHEN THE CATHETER FULL RETRACTS THEN STICKS OUT JUST SLIGHTLY. WHEN IT DOES THIS, IT BRINGS WITH IT A LITTLE OF THE PATIENTS BLOOD. ON FRIDAY, ONCE OF MY ACE IV START PERSONNEL <WHO HAPPENS TO ALSO BE PREGNANT AT THIS TIME> WAS CUT BY THE PLASTIC PIECE THAT HAD SOME OF THE PATIENTS BLOOD ON IT. I WAS TOLD THAT A SIMILAR THING HAPPENED TO AN L&D NURSE AS WELL. YOU CAN SEE FROM A VERY CLOSE INSPECTION OF THE PIC THAT TINY PLASTIC PIECE THAT STICKS OUT. HELLO JUST AN UPDATE. SHE (MOTHER-TO-BE) WAS STUCK BY THE PLASTIC PIECE WHICH JETS OUT ON TOP OF THE IV CATH. I AM TAPING IT TO A PIECE OF PAPER AND STICKING IT IN YOUR MAILBOX. SHE WAS USING THE CATH CORRECTLY, NO VARIANCES. UNFORTUNATELY, IT DID DRAW BLOOD AND SHE HAD TO GO TO EMP HEALTH. DURING HER VISIT, SHE WAS TOLD BY EMP HEALTH STAFF THAT SOMEONE ELSE FROM THE FLOOR HAD ALSO BEEN STUCK IN THE SAME FASHION. SO 2 RNS STUCK BY THESE IV CATHS!!! BASICALLY, THE PLASTIC RETRACTION SHEATH RETRACTS SO FAR THAT A TINY, VERY SHARP PIECE IS LEFT STICKING UP. PERHAPS THIS IS INFORMATION THAT CAN BE SHARED? AT THIS TIME, THERE HAS BEEN NO IV REPS SEEN OR HEARD FROM." 1 OF 2 COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1078179 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 9170536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |