MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PERCUTANEOUS SHEATH INTRODUCER SET; CATHETER, PERCUTANEOUS

Model Number I305BF9

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2015

Event Type  No Answer Provided  

Manufacturer Narrative

We received one intro-flex kit from reported model and lot number in original package for examination.As received into laboratory, the seal had been opened on three sides of the (b)(6) pouch.The opened seal condition of the returned kit did not appear consistent with photo from customer in which the seal was opened just at the bottom left corner.The guide wire had removed from the tube and the needles were also removed from the syringes.Two white non-vented caps were missing from the kit.Adhesive was evident at the opened seal.The adhesive transfer appeared complete without any visual interruption.The opened seal area was further opened at both ends by the lab for inspection and comparison.Both opened seal areas appeared complete without interruption in adhesive transfer.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that, prior to use, the package of the introducer was found to be open at the left corner.It could not be confirmed if this tray came out the box this way.The issue was resolved by using another introducer that was found correctly packed.

Manufacturer Narrative

Corrected a typo in the model number.Correct model number- i305bf9.

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER SET
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5234365
• MDR Text Key: 31572769
• Report Number: 2015691-2015-03137
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K831729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2016
• Device Model Number: I305BF9
• Device Lot Number: 59727631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2014
• 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