BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

Report

Report Number: 2243072-2023-01030
Event Type: Injury
Date Received: June 15, 2023
Date of Event: May 22, 2023
Report Date: March 13, 2025
Manufacturer: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
Product Code: FOZ
UDI-DI: 30382903835127
PMA / PMN Number: K102520
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS DIFFICULT WOULD NOT ADVANCE (THREADING DIFFICULTY) DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR RNS WAS INSERTING THE PATIENT'S IV IN THE VEIN, GOT GOOD BLOOD RETURN. EE FELT RESISTANCE THREADING THE CATHETER. EE HELD STABILIZER HUB AND PULLED OUT THE NEEDLE BUT THE CATHETER AND THE NEEDLE BOTH CAME OUT AND THE NEEDLE PENETRATED EE'S GLOVE. EE FELT SOMETHING SHARP ON HER RIGHT THUMB BUT THE NEEDLE DIDN'T PUNCTURE HER SKIN. WE HAD ANOTHER EE IN OUR DEPARTMENT THAT EXPERIENCED RESISTANCE WITH THE NEXIVA IV CATHETERS TWO MONTHS AGO AND IT RESULTED IN A NEEDLE STICK. WE DO A HIGH VOLUME OF IV STARTS IN THE GI LAB AND FEEL THE NEXIVA CATHETERS ARE DEFECTIVE AND ARE RESULTING IN NEEDLE STICK INJURIES WITH OUR NURSES. D1: MEDICAL DEVICE BRAND NAME: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. D4: UDI #: (B)(4). D4: MEDICAL DEVICE CATALOG #: 383512. D4: MEDICAL DEVICE LOT #: 3032874. D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. H4: DEVICE MANUFACTURE DATE: 01-FEB-2023. D4: MEDICAL DEVICE LOT #: 2306107 . D4: MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026. H4: DEVICE MANUFACTURE DATE: 01-FEB-2023. G2: MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.5. PMA / 510(K)#: K183399. H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH TWO PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOTS, 3032874 2306107, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED NO DAMAGE TO THE CATHETER OR ITS TIP IN THE FIRST PHOTO. THERE APPEARED TO BE BLOOD RESIDUE THROUGHOUT THE CATHETER TUBING AND THE NEEDLE WAS FULLY DECOUPLED FROM THE CATHETER ADAPTER. ADDITIONALLY, THE NEEDLE TIP APPEARED TO BE POSITIONED WITHIN THE TIP SHIELD. THERE WAS NO VISIBLE DAMAGE THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE IN THE FIRST PHOTO. THE ENGINEER REVIEWED THE SECOND PHOTO BUT ALL IT SHOWED WAS THE PRODUCT LABEL AND A BIOHAZARD BAG. THE ACTUAL DEVICE WAS NOT VISIBLE IN THE SECOND PHOTO. THEREFORE, BASED OFF THE PROVIDED PHOTOS THE ENGINEER COULD NOT VERIFY THE REPORTED DEFECT. SINCE THERE WAS NO VISIBLE EVIDENCE OF THE REPORTED DEFECT IN THE PROVIDED PHOTOS THE ENGINEER WAS UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THIS ISSUE.

Additional Manufacturer Narrative · 0

H6: INVESTIGATION SUMMARY THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

Additional Manufacturer Narrative · 0

CORRECTION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEXIVA CATHETER WAS DIFFICULT WOULD NOT ADVANCE (THREADING DIFFICULTY) DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR RNS WAS INSERTING THE PATIENT'S IV IN THE VEIN, GOT GOOD BLOOD RETURN. EE FELT RESISTANCE THREADING THE CATHETER. EE HELD STABILIZER HUB AND PULLED OUT THE NEEDLE BUT THE CATHETER AND THE NEEDLE BOTH CAME OUT AND THE NEEDLE PENETRATED EE'S GLOVE. EE FELT SOMETHING SHARP ON HER RIGHT THUMB BUT THE NEEDLE DIDN'T PUNCTURE HER SKIN. WE HAD ANOTHER EE IN OUR DEPARTMENT THAT EXPERIENCED RESISTANCE WITH THE NEXIVA IV CATHETERS TWO MONTHS AGO AND IT RESULTED IN A NEEDLE STICK. WE DO A HIGH VOLUME OF IV STARTS IN THE GI LAB AND FEEL THE NEXIVA CATHETERS ARE DEFECTIVE AND ARE RESULTING IN NEEDLE STICK INJURIES WITH OUR NURSES.

Additional Manufacturer Narrative · 0

B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

Additional Manufacturer Narrative · 0

(B)(4) FOLLOW UP REPORT FOR CORRECTION. THE SI WAS REPORTED IN ERROR AND DOES NOT MEET THE FDA GUIDANCE FOR A SI NSI. ANNEX F CODE UPDATED FROM F12 - SERIOUS INJURY/ILLNESS/IMPAIRMENT TO F11 - MINOR INJURY/ ILLNESS / IMPAIRMENT. BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUE(B)(6), 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON (B)(6) 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON (B)(6) 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS (B)(4).¿ SAVE AND ENTER YOUR CREDENTIALS:

Additional Manufacturer Narrative · 0

(B)(4) FOLLOW UP REPORT FOR CORRECTION. PREVIOUS DOCUMENTATION DOES NOT APPLY TO THIS RECORD. "BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS (B)(4).¿