INTERLINK INJECTION SITE
Received Nov 22, 2019 · Event occurred Nov 5, 2019
Report 2243072-2019-02642 · MDR key 9364280
Device
Product problems
- Break
- Leak/Splash
- Break
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
H.6. INVESTIGATION: NO ABNORMALITIES WERE FOUND IN THE APPEARANCE OF THE RETURNED OR UNUSED PRODUCT. WHEN A CANNULA WAS CONNECTED TO THE INJECTION SITE, IT WAS CONFIRMED THAT BOTH COULD BE INSERTED WITHOUT ANY PROBLEM. A JIG FOR CHECKING THE SLIT POSITION WAS CONNECTED TO THE INJECTION SITE, AND A PIN GAUGE WITH THE SPECIFIED THICKNESS WAS INSERTED. ALL PASSED WITHOUT ANY PROBLEM, AND NO OBSTRUCTION OF THE FLOW PATH WAS OBSERVED. NO ABNORMALITIES RELATED TO THIS EVENT WERE FOUND IN THE MANUFACTURING PROCESS OF THE LOT. NO ABNORMALITY WAS FOUND IN THE FUNCTIONAL TEST, SO THE CAUSE COULD NOT BE IDENTIFIED.
Description of Event or Problem
IT WAS REPORTED THAT DAMAGE OCCURRED WITH A INTERLINK INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER COULDN'T FLASH."
Additional Manufacturer Narrative
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. THE REPORTED LOT# SPP069 WAS NOT FOUND FOR THE CATALOG NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT DAMAGE OCCURRED WITH A INTERLINK INJECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER COULDN'T FLASH."