BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
Report
- Report Number
- 1024879-2022-00195
- Event Type
- Malfunction
- Date Received
- April 6, 2022
- Date of Event
- March 21, 2022
- Report Date
- August 4, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- FMI
- UDI-DI
- 00382903686070
- PMA / PMN Number
- K982541
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION SUMMARY: "MATERIAL #: 368607. LOT/BATCH #: 1202046. BD RECEIVED 48 SAMPLES AND 4 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR NEEDLE POINT CAUSING PAINFUL VENIPUNCTURE WITH THE INCIDENT LOT WAS NOT OBSERVED AS NO DEFECTS WERE SEEN. ADDITIONALLY, 30 OF THE CUSTOMER SAMPLES ALONG WITH 10 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION FOR CANNULA DEFECTS AND INSUFFICIENT LUBE COVERAGE AND NO ISSUES WERE OBSERVED RELATING TO NEEDLE POINT CAUSING PAINFUL VENIPUNCTURE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE NEEDLE POINT CAUSING PAINFUL VENIPUNCTURE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS." THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 05-AUG-2022.
H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR NEEDLE POINT INTEGRITY ISSUES WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION FOR NEEDLE POINT INTEGRITY ISSUES AS WELL AS SUFFICIENT LUBE COVERAGE AND NO ISSUES WERE OBSERVED THAT COULD CAUSE A PAINFUL VENIPUNCTURE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE NEEDLE POINT INTEGRITY ISSUES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE DEVICE EXPERIENCED MOLDING DEFECTS SHORT SHOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORTED BATCH PRESENTS A DEFORMITY IN THE BEVEL, WHICH CAUSES DIFFICULT IN ITS INTRODUCTION THROUGH THE SKIN, IT ALSO MAKES A STRANGE NOISE AND CAUSES PAINFUL VENIPUNCTURE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE DEVICE EXPERIENCED MOLDING DEFECTS SHORT SHOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORTED BATCH PRESENTS A DEFORMITY IN THE BEVEL, WHICH CAUSES DIFFICULT IN ITS INTRODUCTION THROUGH THE SKIN, IT ALSO MAKES A STRANGE NOISE AND CAUSES PAINFUL VENIPUNCTURE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE DEVICE EXPERIENCED MOLDING DEFECTS SHORT SHOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE REPORTED BATCH PRESENTS A DEFORMITY IN THE BEVEL, WHICH CAUSES DIFFICULT IN ITS INTRODUCTION THROUGH THE SKIN, IT ALSO MAKES A STRANGE NOISE AND CAUSES PAINFUL VENIPUNCTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1821834 | BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON & CO., (BD) | 1202046 | 00382903686070 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |