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

Catalog Number EMC3320P

Device Problems Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Three samples were received for evaluation.The samples underwent visual inspection with the naked eye, it was confirmed that the pouches were open.Further visual inspection with the naked eye revealed that the seal created on the pouch was weak.The reported issue was verified.The cause was determined to be, due to human error during manufacturing, the packing film is received as a reel and loaded on the packaging machine.However, in this case, the reel was mistakenly loaded in reverse, (left edge on the right) resulting in the adhesive side on the outside of the pouch.It was determined that by replacing the two-way bearing with an identical one-way bearing, this would inhibit the user loading the reel in reverse.The installation of the one-way bearing was completed on the 17th june 2017.At the time of production and during in process testing, the seal conformed to standard and any non-conformities would have been noticed.Furthermore, as a precaution it is noted that the pouch instructions state ¿do not use if package has been previously opened or damaged or if sterility protectors are loose or missing¿.A batch review was conducted and there were no deviations found related to this reported condition during the manufacturer of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the sealing of the three (3) access basic solution sets were faulty and the opening was present.This was noted prior to patient's use.There was no patient involvement.No additional information available.

• Brand Name: INTERLINK SYSTEM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - MALTA; marsa
• Manufacturer (Section G): BAXTER HEALTHCARE - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7948803
• MDR Text Key: 123962796
• Report Number: 1416980-2018-06440
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EMC3320P
• Device Lot Number: 15J31V268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1