ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
Report
- Report Number
- 3006425876-2020-00975
- Event Type
- Malfunction
- Date Received
- November 5, 2020
- Date of Event
- October 8, 2020
- Report Date
- October 13, 2020
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DQY
- PMA / PMN Number
- K862056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
QN# (B)(4). THE CUSTOMER RETURNED AN INTRODUCER NEEDLE FOR EVALUATION. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE RETURNED NEEDLE HUB AND NEEDLE CANNULA. VISUAL EXAMINATION REVEALED THE NEEDLE CANNULA WAS SEPARATED FROM THE NEEDLE HUB. MICROSCOPIC EXAMINATION REVEALED THERE WAS LITTLE TO NO ADHESIVE RESIDUE ON THE NEEDLE CANNULA AND THE NEEDLE HUB. THE NEEDLE CANNULA OUTER DIAMETER MEASURED 0.0499", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0495"-0.0505" PER THE CANNULA GRAPHIC. THE CANNULA INNER DIAMETER MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA PRODUCT DRAWING. THE INNER DIAMETER OF THE DISTAL END OF THE NEEDLE HUB MEASURED 0.059", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.0585-0.0605" PER THE HUB GRAPHIC. THE NEEDLE CANNULA WAS ABLE TO BE EASILY REMOVED AND RE-INSERTED INTO THE NEEDLE HUB. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A NEEDLE CANNULA DETACHED FROM THE HUB IN USE WAS CONFIRMED BY COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE CANNULA HAD COMPLETELY DETACHED FROM THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RECEIVED, MANUFACTURING (ASSEMBLY) CAUSED OR CONTRIBUTED TO THIS EVENT. A NONCONFORMANCE REQUEST HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.
(B)(4). CORRECTED DATA: SECTION H.6. INVESTIGATION FINDINGS CODE CORRECTED TO 3252. INVESTIGATION CONCLUSION CODE CORRECTED TO 4315. INVESTIGATION CONCLUSION CORRECTED TO: THE REPORT OF A NEEDLE CANNULA DETACHED FROM THE HUB IN USE WAS CONFIRMED BY COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE CANNULA HAD COMPLETELY DETACHED FROM THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON SALES HISTORY WITH NO RELEVANT FINDINGS. A NONCONFORMANCE REQUEST WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. HOWEVER, BASED ON THE RESULTS OF THE MANUFACTURING EVALUATION, THE ROOT CAUSE IS UNKNOWN. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
CUSTOMER REPORTED THAT "AFTER THE INTRODUCTION OF THE NEEDLE, WHEN THE GUIDE WAS PLACED A CRACK AT THE NEEDLE HUB WAS NOTICED". IT WAS REPORTED THE HUB BROKE OFF COMPLETELY. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
CUSTOMER REPORTED THAT "AFTER THE INTRODUCTION OF THE NEEDLE, WHEN THE GUIDE WAS PLACED A CRACK AT THE NEEDLE HUB WAS NOTICED". IT WAS REPORTED THE HUB BROKE OFF COMPLETELY. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
(B)(4).
CUSTOMER REPORTED THAT "AFTER THE INTRODUCTION OF THE NEEDLE, WHEN THE GUIDE WAS PLACED A CRACK AT THE NEEDLE HUB WAS NOTICED". IT WAS REPORTED THE HUB BROKE OFF COMPLETELY. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1256161 | ARROW CVC SET: 3-LUMEN 8.5FR X 20CM | CATHETER, PERCUTANEOUS | DQY | ARROW INTERNATIONAL INC. | IPN030779 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NONE REPORTED.| NONE REPORTED.| NONE REPORTED. |