MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES; TUBING, FLUID DELIVERY

Catalog Number MX448HL60

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

One infusion extension set was returned for evaluation.Sample underwent functional testing to detect for leakage.No leakage was observed, therefore customer reported complaint was not confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

Event Description

Information was received that while a smiths medical infusion extension set was in use in the nicu, it was noted to be leaking at the connection.It was noted to be about 8 cm x 10 cm area.A piv was placed, as well as labs drawn for complete blood count.Hematocrit was reported to have dropped from 42 to 30, and red blood cells were ordered to be transfused.The pharmacy was notified to send stat total parental nutrition for piv.

• Brand Name: SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8601171
• MDR Text Key: 144745720
• Report Number: 3012307300-2019-02584
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 10351688507426
• UDI-Public: 10351688507426
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: MX448HL60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention