MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SAFE-T HOLDER DEVICE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number REF 96000

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

Event Type  malfunction  

Event Description

Nurse was drawing blood from right picc for am labs.Nurse loosened "safe-t holder device" with male luer adapter from "bd max zero needleless connector" on the red port of the pt's picc line when the nurse heard a snapping sound.Nurse noted that blood continued to exit from red port of the pt's picc.Nurse immediately clamped and changed the "bd max zero needleless connector" from the pt and withdrew blood from the picc line.It is unk as to which part is defective safe-t holder device info: smiths medical, ref (b)(4): (b)(6), lot 3806939, gtin (b)(4), exp 05/10/2024; max zero needleless connector, ref: (b)(4), lot (10) 19026879, exp 02/26/2022.Fda safety report id# (b)(4).

• Brand Name: SAFE-T HOLDER DEVICE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 9490735
• MDR Text Key: 171977196
• Report Number: MW5091723
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/10/2024
• Device Catalogue Number: REF 96000
• Device Lot Number: 38066936
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR