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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MALTA INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameINTERLINK SYSTEM
Type of DeviceSET, 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 Key7948803
MDR Text Key123962796
Report Number1416980-2018-06440
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberEMC3320P
Device Lot Number15J31V268
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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