INJECTOR LOCKING N40-O
Report
- Report Number
- 3003152976-2021-00617
- Event Type
- Malfunction
- Date Received
- September 21, 2021
- Date of Event
- July 19, 2021
- Report Date
- November 22, 2021
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- PMA / PMN Number
- K201099
- Product Problem
- 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 WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: INJECTOR LOCKING N40-O. D.2. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. D.2. MEDICAL DEVICE CATALOG #: 515056. D.3. MEDICAL DEVICE MANUFACTURER: SAN AGUSTIN. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. D.4. MEDICAL DEVICE LOT #: 2104301. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SAN AGUSTIN. G.5. PMA/510(K)#: K201099. H.4. DEVICE MANUFACTURE DATE: 2021-04-09.
H.6. INVESTIGATION: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. EIGHTEEN RETAINED SAMPLES FROM EACH LOT WERE EVALUATED, AND LUER LOCK MEASURED, NO DAMAGE OR DEFECTS OBSERVED, MEASUREMENTS MET ACCEPTANCE CRITERIA. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2104301 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
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 (B)(4) HAS BEEN LISTED. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 18 AUGUST, 2021. MEDWATCH REPORT # MW5103059. REPORT SOURCE OTHER: MEDWATCH REPORT. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA IS NOT REQUIRED AT THIS TIME.
IT WAS REPORTED THAT INJECTOR LOCKING N40-O DISCONNECTED FROM THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE INJECTOR PIECE HAD DISCONNECTED FROM THE CONNECTOR PIECE THAT WAS ATTACHED TO THE PT'S PORT. VERBATIM: A(B)(6) (MIDAS 21-15595) PT WAS SITTING ON CHAIR, NOT MOVING AROUND OR TOUCHING THE TUBING. IV PUMP BEEPED OCCLUDED. I FOLLOWED THE IV TUBING TO CHECK FOR CLAMPS AND NOTED THAT THE INJECTOR PIECE HAD DISCONNECTED FROM THE CONNECTOR PIECE THAT WAS ATTACHED TO THE PT'S PORT. WHEN REATTACHING THE PIECES I FELT RESISTANCE KEEPING THE 2 PIECES TOGETHER. I USED THE SUITCASE TO KEEP THE 2 ATTACHED. PER MOTHER, TUBING HAS BECOME DISCONNECTED BEFORE.
IT WAS REPORTED THAT INJECTOR LOCKING N40-O DISCONNECTED FROM THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE INJECTOR PIECE HAD DISCONNECTED FROM THE CONNECTOR PIECE THAT WAS ATTACHED TO THE PT'S PORT. VERBATIM: A(B)(6) (MIDAS 21-15595) PT WAS SITTING ON CHAIR, NOT MOVING AROUND OR TOUCHING THE TUBING. IV PUMP BEEPED OCCLUDED. I FOLLOWED THE IV TUBING TO CHECK FOR CLAMPS AND NOTED THAT THE INJECTOR PIECE HAD DISCONNECTED FROM THE CONNECTOR PIECE THAT WAS ATTACHED TO THE PT'S PORT. WHEN REATTACHING THE PIECES I FELT RESISTANCE KEEPING THE 2 PIECES TOGETHER. I USED THE SUITCASE TO KEEP THE 2 ATTACHED. PER MOTHER, TUBING HAS BECOME DISCONNECTED BEFORE.
IT WAS REPORTED THAT UNSPECIFIED BD¿ INJECTOR DISCONNECTED FROM THE CONNECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE INJECTOR PIECE HAD DISCONNECTED FROM THE CONNECTOR PIECE THAT WAS ATTACHED TO THE PT'S PORT. VERBATIM: A(B)(6) (MIDAS 21-15595) PT WAS SITTING ON CHAIR, NOT MOVING AROUND OR TOUCHING THE TUBING. IV PUMP BEEPED OCCLUDED. I FOLLOWED THE IV TUBING TO CHECK FOR CLAMPS AND NOTED THAT THE INJECTOR PIECE HAD DISCONNECTED FROM THE CONNECTOR PIECE THAT WAS ATTACHED TO THE PT'S PORT. WHEN REATTACHING THE PIECES I FELT RESISTANCE KEEPING THE 2 PIECES TOGETHER. I USED THE SUITCASE TO KEEP THE 2 ATTACHED. PER MOTHER, TUBING HAS BECOME DISCONNECTED BEFORE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1405848 | INJECTOR LOCKING N40-O | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 2104301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |