MAUDE Adverse Event Report: BAXTER HEALTHCARE - MALTA INTERLINK SYSTEM; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number EMC3320P

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the packages of an unspecified number of interlink solution administration sets had sealing problems.The reporter stated that the four edges of the packages were randomly peeling off.This was noted before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Eight (8) devices were received for evaluation.A visual inspection using the naked eye was performed and observed that the seals in the pouch were weak.The reported condition was verified.The cause of the event was due to the packaging machine reel was mistakenly loaded in reverse, (left edge on the right) resulting in the adhesive side on the outside of the pouch.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SYSTEM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• MDR Report Key: 8441554
• MDR Text Key: 139614285
• Report Number: 1416980-2019-01528
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413760241050
• UDI-Public: (01)05413760241050
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: EMC3320P
• Device Lot Number: 15J31V268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1