MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N1191
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) non-dehp y-type catheter extension sets broke (one tubing separated from the male luer and one tubing separated from the y-junction).This was identified during patient use.The sets were connected to tpn (total parenteral nutrition)/lipids and were replaced to continue therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.H10: two (2) actual samples were received for evaluation.Visual inspection was performed using the naked eye which observed that the tubing was separated from the connector on one of the samples and the micro bore bifurcated ¿y¿¿ junction on the other sample.Inspection observed the insertion of the tubes were correct during assembly and according to specification.However, additional inspection observed excess solvent on both tubes.The reported condition was verified.The cause of the condition was due to an excess solvent applied during manual assembly process.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: RADIATION STERILIZED EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10179620
• Report Number: 1416980-2020-03492
• Device Sequence Number: 14345867
• Product Code: FPA
• UDI-Device Identifier: 00085412004532
• UDI-Public: (01)00085412004532
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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
• Operator of Device: Other
• Device Catalogue Number: 2N1191
• Device Lot Number: R20A14138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION/LIPIDS; TOTAL PARENTERAL NUTRITION/LIPIDS