AMPLATZ RENAL DILATOR SET
Received Jun 20, 2025 · Event occurred Mar 25, 2025
Report 1820334-2025-00742 · MDR key 22298640
Device
Product problems
- Tear, Rip or Hole in Device Packaging
- Tear, Rip or Hole in Device Packaging
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED FOUR PACKAGES OF AMPLATZ RENAL DILATOR SETS ARRIVED DAMAGED (BROKEN). IT HAS BEEN REPORTED THAT HANDLING CONDITIONS DURING TRANSPORTATION FROM THE MANUFACTURER TO CUSTOMS OF THE RECEIVING COUNTRY MAY HAVE CONTRIBUTED TO THE ISSUE. THE DEVICES DID NOT MAKE PATIENT CONTACT, AND NO ADVERSE EFFECTS HAVE BEEN REPORTED. A CUSTOMER PROVIDED PHOTOS APPEAR TO SHOW A HOLE IN THE PACKAGING.
Additional Manufacturer Narrative
H3: DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
Additional Manufacturer Narrative
CORRECTION: B1, H1: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. AS SUCH, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT; NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED. FOUR COMPLAINT DEVICES WERE RETURNED ON 25JUN2025 A REVIEW OF THE PRELIMINARY DFA AND INVESTIGATION PHOTOS SHOW ALL 4 APPEAR TO HAVE WRINKLED AND FOLDED PACKAGING, HOWEVER NO SEALS APPEAR TO BE BREACHED AND THE STERILE BARRIER DOES NOT APPEAR TO BE COMPROMISED. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR PATIENT DEATH. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.