MAUDE Adverse Event Report: COLOPLAST A/S ELEFANT SUCTION-IRRIGATION DEVICE; LAVAGE, JET

Model Number	ASP1651002
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, the external packaging was defective and sterility of the device could not be guaranteed.
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Additional Manufacturer Narrative
The device was received for evaluation with the packaging torn at the top of the bag.Investigation determined that during manufacturing there is nothing sharp that could cause a tear in the pouch.The cannula couldn't have caused the tear, as the inner packaging was intact, and the force required to push the outer pouch would have pushed it through both the inner and outer pouches.Investigation determined that the package was most likely torn manually by hand outside of production.

• Brand Name: ELEFANT SUCTION-IRRIGATION DEVICE
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13171632
• Report Number: 9610711-2022-00003
• Device Sequence Number: 4158920
• Product Code: FQH
• UDI-Device Identifier: 03600040210598
• UDI-Public: 03600040210598
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2026
• Device Model Number: ASP1651002
• Device Catalogue Number: ASP165
• Device Lot Number: 8134015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown