MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULAIDE SIZE 2, FOR BABIES 1250G-2000G,

Model Number CA102-0-25

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Erosion (2075); Skin Tears (2516)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

Product extremely rigid.Causing skin breakdown.

Manufacturer Narrative

The reported event of: product extremely rigid.Causing skin breakdown.All information reasonably known as of 24 apr 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife database complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an sunmed holdings llc.Product is defective or caused serious injury.

• Brand Name: SALTER LABS
• Type of Device: CANNULAIDE SIZE 2, FOR BABIES 1250G-2000G,
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 19177116
• MDR Text Key: 341685138
• Report Number: 3000219639-2024-00039
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10607411007160
• UDI-Public: 10607411007160
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CA102-0-25
• Device Catalogue Number: CA102-0-25
• Device Lot Number: 45205-1-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other