BD INFUSION SET SA200 W/O LL¿
Received Dec 2, 2021 · Event occurred Nov 3, 2021
Report 2243072-2021-02854 · MDR key 12921698
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2243072-2021-02854 WAS SENT IN ERROR THIS IS NOT A BD PRODUCT AND IS THEREFORE NOT REPORTABLE. H3 OTHER TEXT : SEE H10.
Description of Event or Problem
IT WAS REPORTED WHEN USING THE BD INFUSION SET SA200 W/O LL¿ THERE WAS AN IV SET LOOSE CONNECTION, SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS A "DISCONNECTION OF THE CHAMBER AND SPIKE ON THE BASIC IV SET."
Additional Manufacturer Narrative
OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. 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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHEN USING THE BD INFUSION SET SA200 W/O LL¿ THERE WAS AN IV SET LOOSE CONNECTION, SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS A "DISCONNECTION OF THE CHAMBER AND SPIKE ON THE BASIC IV SET."