BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS
Report
- Report Number
- 3006260740-2023-02989
- Event Type
- Injury
- Date Received
- July 14, 2023
- Date of Event
- June 6, 2023
- Report Date
- July 27, 2023
- Manufacturer
- C.R. BARD, INC. (BASD) -3006260740
- Product Code
- FPA
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 14-AUG-2023. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. THE ACTUAL USED SAMPLES WERE NOT AVAILABLE FOR INVESTIGATION. BD RECEIVED ALL AVAILABLE LOT NUMBERS FROM UPMC DIRECTLY THAT WERE HELD IN THEIR INVENTORY. BELOW IS A LIST OF PRODUCT SAMPLES RECEIVED: LOT REF # EXPIRATION DATE TOTAL RECEIVED FROM UPMC 9451758 201-0006 2025-03-08 (B)(4) 9451859 201-0006 2025-03-24 (B)(4) 9452225 201-0006 2025-05-10 (B)(4) 9452811 201-0006 2025-08-18 (B)(4) 9453200 201-0006 2025-09-22 (B)(4) 9453333 201-0006 2025-10-11 (B)(4) 9453399 201-0006 2025-10-24 (B)(4). THE REPORTS INDICATED DIFFICULTY WITH THE IV SITE. WHILE FLUSHING THE IV SITE, BACK PRESSURE IN THE IV LEAD TO SPRAY FROM THE DEVICE RESULTING IN EXPOSURE TO THE CLINICIANS. A FUNCTIONAL TEST REVEALED ALL SAMPLES MET THE BACK PRESSURE REQUIREMENT PER THE SPECIFICATION. WHILE THE ROOT CAUSE OF THIS ISSUE COULD NOT BE ESTABLISHED, POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED EVENT INCLUDE FLUSHING AGAINST RESISTANCE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
E.4. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 13-JUN-2023. MEDWATCH REPORT # MW5118435. H.3. 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 WHILE FLUSHING WITH BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS WHEN FLUSHED THE IV SITE SPRAYED RN IN THE RIGHT EYE. INFORMATION REGARDING INTERVENTION GIVEN TO HCP'S HAS NOT YET BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED RN (REGISTERED NURSE) WENT IN TO FLUSH PATIENTS IV (INTRAVENOUS) AND HANG ANTIBIOTIC AND FLUIDS AND WHEN RN FLUSHED THE IV IT SHOT BACK AT HER THROUGH THE PIVO PORT AND SHOT HER IN HER RIGHT EYE.
IT WAS REPORTED THAT WHILE FLUSHING WITH BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS WHEN FLUSHED THE IV SITE SPRAYED RN IN THE RIGHT EYE. INFORMATION REGARDING INTERVENTION GIVEN TO HCP'S HAS NOT YET BEEN OBTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED RN (REGISTERED NURSE) WENT IN TO FLUSH PATIENTS IV (INTRAVENOUS) AND HANG ANTIBIOTIC AND FLUIDS AND WHEN RN FLUSHED THE IV IT SHOT BACK AT HER THROUGH THE PIVO PORT AND SHOT HER IN HER RIGHT EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426363 | BD EXT¿ STABILIZED EXTENSION SET WITH NEARPORT¿ IV ACCESS | INTRAVASCULAR ADMINISTRATION SET | FPA | C.R. BARD, INC. (BASD) -3006260740 | 201-0006 | 9453333 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |