MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEMEROL VENOUS CANNULA

Model Number VFEM022

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

Edwards was notified that three cannulas were received in wet cartons with signs of moisture inside the sterile package.

Manufacturer Narrative

Any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.The device is in the process of being returned.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

H3: product evaluation: customer report of moisture inside the sterile package was not confirmed in any of the three samples.Sample 1 as received no moisture or signs of moisture were noticed, however the left area of outer carton box was noticed curvy and inner layer of the carton box lid was found detached.Inner tab was also found curvy and folded inward.Inner packing was free of any visible damage or moisture.Sample 2 as received no moisture or signs of moisture were noticed, however the left area of outer carton box was noticed curvy and inner layer of the carton box lid was found detached.Inner packing was free of any visible damage or moisture.Sample 3 as received no moisture or signs of moisture were noticed, however from middle to the right area of outer carton box the box lid was noticed curvy.Inner packing was free of any visible damage or moisture.All three returned units appeared consistent with customer photos, however water drops were not visible.

Manufacturer Narrative

H10: additional narratives.Updated d4, h4, and h6 per new information received.The root cause of this event cannot be conclusively determined.However, it is likely that the units were exposed to moisture during storage/transportation in route to the customer.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: FEMEROL VENOUS CANNULA
• Type of Device: FEMEROL VENOUS CANNULA
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; one edwards way; mailstop 6.1 anton; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12729723
• MDR Text Key: 282412823
• Report Number: 2015691-2021-06103
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00690103146660
• UDI-Public: (01)00690103146660(17)230811(11)2008112163331136
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K891576
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2022

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
• Device Expiration Date: 08/11/2023
• Device Model Number: VFEM022
• Device Catalogue Number: VFEM022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/01/2021
• Supplement Dates Manufacturer Received: 11/18/2021; 12/23/2021
• Supplement Dates FDA Received: 11/30/2021; 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1