BD INSYTE AUTOGUARD
Report
- Report Number
- 9610048-2024-00008
- Event Type
- Malfunction
- Date Received
- February 5, 2024
- Date of Event
- January 5, 2024
- Report Date
- July 26, 2024
- Manufacturer
- BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
- Product Code
- FOZ
- PMA / PMN Number
- UNK
- Removal / Correction Number
- MDS-24-5036-FA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3062305. THE REVIEW DID IDENTIFY RECORDS RELATING THE CATHETER TIP FORMATION AND ADJUSTMENTS THAT WERE MADE DURING PRODUCTION TO IMPROVE CATHETER QUALITY. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ALTHOUGH THE IMAGE WAS SLIGHTLY BLURRED, IT WAS POSSIBLE TO VERIFY THAT THE ADAPTER COMPONENT WAS LIFTING AND THAT THE CATHETER WAS WITHOUT A TIP. FOR FURTHER ANALYSIS, THE PHYSICAL SAMPLE WOULD BE NECESSARY. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ISSUE WITH THE CATHETER TIP FORMATION. A CATHETER WITH A POORLY FORMED TIP CAN CAUSE THE ADAPTER TO EASILY DETACH FROM THE CANNULA. WE ARE CONDUCTING A VOLUNTARY RECALL OF THE AFFECTED CATHETERS BD INSYTE FOR CERTAIN CATALOGS AND LOT NUMBERS. THE AFFECTED CATHETER TIP MAY RESULT IN RESISTANCE WITH THE CATHETER INSERTION PROCESS. THE POTENTIAL IMMEDIATE HEALTH CONSEQUENCES ASSOCIATED WITH THE ABOVE, INCLUDE PAIN /DISCOMFORT, VESSEL INJURY, VASCULITIS, TISSUE INJURY, BLEEDING, DELAY IN PROCEDURE AND NEED FOR ADDITIONAL DEVICE INSERTION. IT IS ALSO POSSIBLE FOR THERE TO BE NO HEALTH EFFECTS RELATED TO THE USE OF THE STRAIGHT EDGED TIP. LONG TERM HEALTH CONSEQUENCES WOULD NOT BE EXPECTED; HOWEVER, MAY BE PRESENT ONLY AS A RESULT OF THE IMMEDIATE HEALTH CONSEQUENCE. IT IS RECOMMENDED THAT CLINICIANS USE STANDARD CLINICAL PRACTICE OF INSPECTION OF THE DEVICE PRIOR TO INSERTION. IF THE CLINICIAN DOES NOT NOTICE THE CATHETER TIP EDGE, THEY ARE INSTRUCTED TO STOP THE INSERTION PROCEDURE IF PAIN OR RESISTANCE OUT OF PROPORTION TO THE PROCEDURE IS NOTED. IF A DEFECTIVE PRODUCT IS INSERTED, MONITORING FOR TISSUE, VESSEL AND SKIN DAMAGE IS RECOMMENDED. IF ANY SYMPTOMS OCCUR, IT IS RECOMMENDED TO REMOVE THE PRODUCT AND REPLACE WITH A NEW PRODUCT IF CLINICALLY INDICATED. WE ARE INVESTIGATING AND WILL IMPLEMENT APPROPRIATE MEASURES TO PREVENT RECURRENCE OF THIS PRODUCT ISSUE. A CORRECTIVE AND PREVENTIVE ACTION PLAN IS IN PROGRESS. PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THE PRODUCT ISSUE AND RETRAINED TO THE PROCEDURES TO INCREASE AWARENESS. PLEASE SEE THE PROVIDED RECALL NOTICE (A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3062305. THE REVIEW DID IDENTIFY RECORDS RELATING THE CATHETER TIP FORMATION AND ADJUSTMENTS THAT WERE MADE DURING PRODUCTION TO IMPROVE CATHETER QUALITY. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ALTHOUGH THE IMAGE WAS SLIGHTLY BLURRED, IT WAS POSSIBLE TO VERIFY THAT THE ADAPTER COMPONENT WAS LIFTING AND THAT THE CATHETER WAS WITHOUT A TIP. FOR FURTHER ANALYSIS, THE PHYSICAL SAMPLE WOULD BE NECESSARY. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ISSUE WITH THE CATHETER TIP FORMATION. A CATHETER WITH A POORLY FORMED TIP CAN CAUSE THE ADAPTER TO EASILY DETACH FROM THE CANNULA. WE ARE CONDUCTING A VOLUNTARY RECALL OF THE AFFECTED CATHETERS BD INSYTE FOR CERTAIN CATALOGS AND LOT NUMBERS. THE AFFECTED CATHETER TIP MAY RESULT IN RESISTANCE WITH THE CATHETER INSERTION PROCESS. THE POTENTIAL IMMEDIATE HEALTH CONSEQUENCES ASSOCIATED WITH THE ABOVE, INCLUDE PAIN /DISCOMFORT, VESSEL INJURY, VASCULITIS, TISSUE INJURY, BLEEDING, DELAY IN PROCEDURE AND NEED FOR ADDITIONAL DEVICE INSERTION. IT IS ALSO POSSIBLE FOR THERE TO BE NO HEALTH EFFECTS RELATED TO THE USE OF THE STRAIGHT EDGED TIP. LONG TERM HEALTH CONSEQUENCES WOULD NOT BE EXPECTED; HOWEVER, MAY BE PRESENT ONLY AS A RESULT OF THE IMMEDIATE HEALTH CONSEQUENCE. IT IS RECOMMENDED THAT CLINICIANS USE STANDARD CLINICAL PRACTICE OF INSPECTION OF THE DEVICE PRIOR TO INSERTION. IF THE CLINICIAN DOES NOT NOTICE THE CATHETER TIP EDGE, THEY ARE INSTRUCTED TO STOP THE INSERTION PROCEDURE IF PAIN OR RESISTANCE OUT OF PROPORTION TO THE PROCEDURE IS NOTED. IF A DEFECTIVE PRODUCT IS INSERTED, MONITORING FOR TISSUE, VESSEL AND SKIN DAMAGE IS RECOMMENDED. IF ANY SYMPTOMS OCCUR, IT IS RECOMMENDED TO REMOVE THE PRODUCT AND REPLACE WITH A NEW PRODUCT IF CLINICALLY INDICATED. WE ARE INVESTIGATING AND WILL IMPLEMENT APPROPRIATE MEASURES TO PREVENT RECURRENCE OF THIS PRODUCT ISSUE. A CORRECTIVE AND PREVENTIVE ACTION PLAN IS IN PROGRESS. PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THE PRODUCT ISSUE AND RETRAINED TO THE PROCEDURES TO INCREASE AWARENESS. PLEASE SEE THE PROVIDED RECALL NOTICE (MDS-24-5036-FA) FOR FURTHER INFORMATION. FOR FURTHER INFORMATION.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3062305. THE REVIEW DID IDENTIFY RECORDS RELATING THE CATHETER TIP FORMATION AND ADJUSTMENTS THAT WERE MADE DURING PRODUCTION TO IMPROVE CATHETER QUALITY. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ALTHOUGH THE IMAGE WAS SLIGHTLY BLURRED, IT WAS POSSIBLE TO VERIFY THAT THE ADAPTER COMPONENT WAS LIFTING AND THAT THE CATHETER WAS WITHOUT A TIP. FOR FURTHER ANALYSIS, THE PHYSICAL SAMPLE WOULD BE NECESSARY. IT IS POSSIBLE THAT THIS INCIDENT RESULTED FROM AN ISSUE WITH THE CATHETER TIP FORMATION. A CATHETER WITH A POORLY FORMED TIP CAN CAUSE THE ADAPTER TO EASILY DETACH FROM THE CANNULA. CORRECTIVE AND PREVENTIVE ACTIONS ARE CURRENTLY UNDERWAY FOR THIS ISSUE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD INSYTE AUTOGUARD BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE PATIENT IS CANALIZED, THE CATHETER BECOMES LOOSE, SO IT IS NECESSARY TO PUNCTURE THE PATIENT AGAIN. OUTLOOK EMAIL TRANSLATION DIFFERS FROM THE ENTRY DESCRIPTION TRANSLATION: "EVENT DESCRIPTION: AT THE TIME OF CHANNELING THE PATIENT, THE CATHETER BLOOMS, SO IT IS NECESSARY TO PUNCTURE THE PATIENT AGAIN". GOOGLE TRANSLATION DIFFERS FROM THE ENTRY DESCRIPTION TRANSLATION: "DESCRIPTION OF THE EVENT: AT THE TIME OF CHANNELING THE PATIENT, THE CATHETER BREAKS, SO IT IS NECESSARY TO PUNCTURE THE PATIENT AGAIN."
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248955 | BD INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. | 3062305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |