BD ALARIS¿ SMARTSITE¿ EXTENSION SET
Report
- Report Number
- 9616066-2023-01005
- Event Type
- Malfunction
- Date Received
- May 23, 2023
- Date of Event
- August 23, 2022
- Report Date
- October 18, 2023
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 10885403234859
- PMA / PMN Number
- K022209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED, DUE TO CORRECTIONS: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED, WHILE USING THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET. LEAKAGE OCCURRED. C.2. CONCOMITANT MED PROD DESC: AS LVP 20D 2SS CV, D.1. MEDICAL DEVICE BRAND NAME: BD ALARIS¿ SMARTSITE¿ EXTENSION SET, D.3. MEDICAL DEVICE CATALOG #: 20027E, D.4. MEDICAL DEVICE LOT #: 22049302, D.4. MEDICAL DEVICE EXPIRATION DATE: 25-APR-2025, D.6. UNIQUE IDENTIFIER (UDI) #: (B)(4), G.5. PMA / 510(K)#: K022209, H.4. DEVICE MANUFACTURE DATE: 21-APR-2022.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES. RETURNED TO MANUFACTURER ON: 18-MAY-2023. INVESTIGATION SUMMARY: ONE USED SAMPLE OF MATERIAL # 2420-0007 WITH THE EXTENSION SET (MAT # 20027E) OF 1.2-MICRON FILTER, 1 SMARTSITE WAS RETURNED FOR QUALITY INVESTIGATION BY THE CUSTOMER. IT WAS REPORTED BY THE CUSTOMER THAT THE SET WAS LEAKING AT JUNCTION BETWEEN TUBING AND FILTER. PRIOR TO FUNCTIONAL TESTING THE WHOLE SAMPLES WERE VISUALLY EXAMINED FOR DEFECTS AND ABNORMALITIES. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SAMPLES WERE THEN SEPARATED AND TESTED BY APPLYING THE PRESSURE TEST WITH WATER USING A 10ML BD SYRINGE TO THE EXTENSION SET TO CONFIRM THE LEAKAGE. THE FAILURE OF LEAKAGE IN FEMALE LUER WITH FLUID DROPLET WAS OBSERVED IN RETURNED SAMPLES AND ISSUE COULD BE REPLICATED BECAUSE OF THE STRAIGHT CRACK IN IT, AND THE COMPLAINT WAS VERIFIED. QUALITY NOTIFICATION SEND TO MANUFACTURER, AND THIS IS NOT A MANUFACTURING ISSUE. A DEVICE HISTORY RECORD REVIEW FOR EXTENSION SET MODEL 20027E AND LOT NUMBER 22049302 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET OF LOT. THE SUPPLIER OF THE FEMALE LUER WAS NOTIFIED, AND THEIR RESPONSE FOUND THAT THERE ARE SOME FACTORS THAT COULD INDICATE THAT THE CRACKED HAPPENED DURING THE USE OF THE PRODUCT. THEY FOUND NO ADDITIONAL ACTIONS ARE REQUIRED.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED, WHILE USING THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET. LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTH OF THESE INCIDENTS OCCURRED, IN (B)(6) 2022 .AND WHILE, NO HARM OCCURRED TO THE PATIENTS, THERE WAS SOME DELAY, AS REPLACEMENT PRODUCTS NEEDED TO BE OBTAINED. THE TWO ITEMS THAT FAILED ARE: 1. BD SECONDARY SET CAT# MS3500-15 WITH LOT# (10) 22013262. DATE OF OCCURRENCE (B)(6) 2022. PROBLEM EXPERIENCED: THE SPIKE BROKE, CAUSING FLUID TO BE SPILLED. WHICH, INCLUDED AN IRON INFUSION. I HAVE THE PRODUCT TO RETURN FOR INSPECTION IF NEEDED. 2. BD PRIMARY SET CAT# 2420-007, LOT# UNKNOWN. DATE OF OCCURRENCE (B)(6) 2022. PROBLEM EXPERIENCED: SET WAS LEAKING AT JUNCTION, BETWEEN TUBING AND FILTER (HOLE?). SPRAYS OUT WHEN FLUSHED AND WAS LEAKING, WHILE ATTACHED TO THE PATIENT. I DO HAVE THIS PRODUCT TO RETURN FOR INSPECTION IF NEEDED.
IT WAS REPORTED WHILE USING THE BD ALARIS¿ SMARTSITE¿ EXTENSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTH OF THESE INCIDENTS OCCURRED IN (B)(6) 2022 AND WHILE NO HARM OCCURRED TO THE PATIENTS, THERE WAS SOME DELAY AS REPLACEMENT PRODUCTS NEEDED TO BE OBTAINED. THE TWO ITEMS THAT FAILED ARE: 1. BD SECONDARY SET CAT# MS3500-15 WITH LOT# (10)22013262 ¿ DATE OF OCCURRENCE 8/22/22. PROBLEM EXPERIENCED ¿ THE SPIKE BROKE CAUSING FLUID TO BE SPILLED WHICH INCLUDED AN IRON INFUSION. I HAVE THE PRODUCT TO RETURN FOR INSPECTION IF NEEDED. 2. BD PRIMARY SET CAT# 2420-007 LOT# UNKNOWN. DATE OF OCCURRENCE 8/23/22. PROBLEM EXPERIENCED ¿ SET WAS LEAKING AT JUNCTION BETWEEN TUBING AND FILTER (HOLE?). SPRAYS OUT WHEN FLUSHED AND WAS LEAKING WHILE ATTACHED TO THE PATIENT. I DO HAVE THIS PRODUCT TO RETURN FOR INSPECTION IF NEEDED.
IT WAS REPORTED WHILE USING BD ALARIS PUMP MODULE SMARTSITE INFUSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BOTH OF THESE INCIDENTS OCCURRED IN (B)(6) 2022 AND WHILE NO HARM OCCURRED TO THE PATIENTS, THERE WAS SOME DELAY AS REPLACEMENT PRODUCTS NEEDED TO BE OBTAINED. THE TWO ITEMS THAT FAILED ARE: BD SECONDARY SET CAT# MS3500-15 WITH LOT# (10)22013262 ¿ DATE OF OCCURRENCE (B)(6)2022. PROBLEM EXPERIENCED ¿ THE SPIKE BROKE CAUSING FLUID TO BE SPILLED WHICH INCLUDED AN IRON INFUSION. I HAVE THE PRODUCT TO RETURN FOR INSPECTION IF NEEDED. BD PRIMARY SET CAT# 2420-007 LOT# UNKNOWN. DATE OF OCCURRENCE (B)(6) 2022. PROBLEM EXPERIENCED ¿ SET WAS LEAKING AT JUNCTION BETWEEN TUBING AND FILTER (HOLE?). SPRAYS OUT WHEN FLUSHED AND WAS LEAKING WHILE ATTACHED TO THE PATIENT. I DO HAVE THIS PRODUCT TO RETURN FOR INSPECTION IF NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848393 | BD ALARIS¿ SMARTSITE¿ EXTENSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | 2420-0007 | 22049302 | 10885403234859 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | AS LVP 20D 2SS CV |