BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER 14G X 1.77 IN
Report
- Report Number
- 8041187-2017-00073
- Event Type
- Injury
- Date Received
- August 11, 2017
- Date of Event
- July 19, 2017
- Report Date
- September 28, 2017
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FOZ
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
MEDICAL DEVICE BRAND NAME: BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER 14G X 1.77 IN, MEDICAL DEVICE CATALOG #: 393230, MEDICAL DEVICE EXPIRATION DATE: 02/29/2017, MEDICAL DEVICE LOT: 7051327, UNIQUE IDENTIFIER (UDI) #: (B)(4), DEVICE MANUFACTURE DATE: 04/24/2017.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT#: UNKNOWN. (B)(6). A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE STICK INJURY REGARDING ITEM # 393270 WITH LOT # 7051327P. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
INVESTIGATION SUMMARY: 1 ACTUAL AND 1 REPRESENTATIVE SAMPLE WAS RETURNED FOR INVESTIGATION. THE ACTUAL SAMPLE IS FROM BATCH #7051327 (CATALOG #393230) AND THE REPRESENTATIVE SAMPLE IS FROM ANOTHER CATALOG BATCH #5294382 (CATALOG #393270). REPRESENTATIVE SAMPLE: THE REPRESENTATIVE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION OF THE V-CLIP, CATHETER TUBING, TETHER FOIL AND CANNULA TIP. MANUAL ACTIVATION OF THE SAFETY MECHANISM WAS ALSO PERFORMED. THERE WAS NO ABNORMALITY OBSERVED AND THE SAMPLE PASSED THE ACCEPTANCE CRITERIA. ACTUAL SAMPLE: THE ACTUAL SAMPLE WAS RETURNED WITHOUT THE CANNULA HUB AND CATHETER ASSEMBLY. A VISUAL INSPECTION WAS PERFORM ON THE V-CLIP. THE V-CLIP HAS BEEN PROPERLY ACTIVATED AND THE CANNULA IS CONTAINED WITHIN THE SAFETY MECHANISM IN THE NEEDLE CAP. INVESTIGATION CONCLUSION: THE REPRESENTATIVE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND MANUAL ACTIVATION TEST. THE SAMPLE PASSED THE ACCEPTANCE CRITERIA. THE ACTUAL SAMPLE WAS RETURNED WITH CANNULA AFTER ACTIVATION. CANNULA IS SECURED IN THE SAFETY MECHANISM AS INTENDED. THERE IS NO SHARP CANNULA EXPOSED. ROOT CAUSE DESCRIPTION: THE NON-CONFORMANCE OF THIS COMPLAINT COULD NOT BE DETERMINED AS THE REPRESENTATIVE SAMPLE PASSED THE ACCEPTANCE CRITERIA AND THE ACTUAL SAMPLE SHOWS THAT THE CANNULA IS PROPERLY SECURED IN THE SAFETY MECHANISM AS INTENDED. RATIONALE: THE REPRESENTATIVE SAMPLE PASSED THE ACCEPTANCE CRITERIA AND THE ACTUAL SAMPLE DOES NOT INDICATE THE FAILURE REPORTED. DHR: COMPLAINT NUMBER: (B)(4), BUSINESS: MPS, CATALOG NUMBER: 393230, PRODUCT DESCRIPTION: VENFLON PRO SAFETY 14GA GERMANY, LOT/BATCH NUMBER: 7051327, EXPIRATION DATE: 29 FEB 2020. RETURNED SAMPLES: 1 ACTUAL SAMPLE RECEIVED, 1 REPRESENTATIVE SAMPLE RECEIVED. NO PHOTO PROBLEM STATEMENT: VERBATIM - OUR NURSE (B)(6) FROM THE OR STUCK HERSELF WITH THIS CANNULA (IN THE ATTACHMENT), AFTER VENIPUNCTURE. THE SAFETY STOPPER WAS NOT FIXED AT THE NEEDLE POINT. I WAS TOLD, THAT IT WAS NOT THE FIRST TIME. DECONTAMINATION: NO SAMPLES RETURNED. RETURNED SAMPLE EVALUATION: 1 ACTUAL SAMPLE RECEIVED AND 1 REPRESENTATIVE SAMPLE RECEIVED. NO PHOTO. RETAIN SAMPLE EVALUATION: NO SAMPLE. CUSTOMER RETURNED SAMPLE DECONTAMINATION STATUS: SAMPLES WERE DECONTAMINATED BY VENDOR. COMPLAINT HISTORY REVIEW: NO SIMILAR COMPLAINT WAS RECEIVED FOR THIS MANUFACTURING LOTS. DHR REVIEW: LOT MASTER FOR BATCH #7051327 (CATALOG #393230) WAS RECEIVED. 1 QUALITY NOTIFICATION WAS RAISED FOR SUSPECTED CANNULA HUB LEAKAGE, BUT THE DEFECT IS NOT RELATED TO THIS COMPLAINT. NEEDLE CAP INCOMING BATCH #5818 AND 5817 (CATALOG #8020417) WAS REVIEWED AND NO QUALITY NOTIFICATION WAS RAISED. V-CLIP SS INCOMING BATCH #I0116-D1-U- AND I0302-D3-U (CATALOG #8025704) WAS REVIEWED AND NO QUALITY NOTIFICATION WAS RAISED. CANNULA SS INCOMING BATCH # J4758911B (CATALOG #8020393) WAS REVIEWED AND NO QUALITY NOTIFICATION WAS RAISED. LOT MASTER FOR BATCH #5294382 (CATALOG #393270) WAS REVIEWED. NO QUALITY NOTIFICATION WAS RAISED FOR THIS VPS BATCH. NEEDLE CAP INCOMING BATCH #150602, 150404, 150403, 150603, 150408 AND 150407 (CATALOG #8020417) WAS REVIEWED AND NO QUALITY NOTIFICATION WAS RAISED. V-CLIP SS INCOMING BATCH # G0117-N1-G AND 486274 (CATALOG #8025704) WAS REVIEWED AND NO QUALITY NOTIFICATION WAS RAISED. CANNULA SS INCOMING BATCH # Q497A AND Y514A (CATALOG #8020393) WAS REVIEWED AND NO QUALITY NOTIFICATION WAS RAISED. MANUFACTURING PROCESS: NO ABNORMALITIES OBSERVED AFTER REVIEWING PREVENTATIVE MAINTENANCE, CALIBRATION AND EQUIPMENT. REFERENCE TO KNOWN ISSUES:N/A. CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. INVESTIGATION COMMENTS: THE REPRESENTATIVE SAMPLE WAS SUBJECTED TO A VISUAL INSPECTION AND MANUAL ACTIVATION TEST. THE SAMPLE PASSED THE ACCEPTANCE CRITERIA. THE ACTUAL SAMPLE WAS RETURNED WITH CANNULA AFTER ACTIVATION. CANNULA IS SECURED IN THE SAFETY MECHANISM AS INTENDED. THERE IS NO SHARP CANNULA EXPOSED. PRODUCT WITHIN SPECIFICATION: NOT ABLE TO DETERMINE. ROOT CAUSE: THE NON-CONFORMANCE OF THIS COMPLAINT COULD NOT BE DETERMINED AS THE REPRESENTATIVE SAMPLE PASSED THE ACCEPTANCE CRITERIA AND THE ACTUAL SAMPLE SHOWS THE CANNULA IS PROPERLY IN THE SAFETY MECHANISM AS INTENDED. CAPA DETERMINATION RESULTS: N/A.
IT WAS REPORTED THAT AN OPERATING ROOM NURSE RECEIVED A NEEDLE STICK TO HER MIDDLE FINGER AFTER VENIPUNCTURE WHILE USING A 14 G BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. THE SAFETY STOPPER WAS FIXED AT THE NEEDLE POINT. LAB TESTS PERFORMED, RESULTS WERE NEGATIVE. NURSE REPORTS SHE WILL FOLLOW-UP WITH ADDITIONAL TESTING IN 6 WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 570459 | BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER 14G X 1.77 IN | INTERVASCULAR CATHETER | FOZ | BECTON DICKINSON MEDICAL (SINGAPORE) | 705137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |