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

Model Number	CA102-0-25
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Skin Erosion (2075); Skin Tears (2516)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Product extremely rigid.Causing skin breakdown.
Additional 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.
Additional Manufacturer Narrative
Correction: b5; h1; additional information: the actual complaint product was not returned for evaluation; however, the reporter provided images of the alleged device.Review of the images did not confirm the reported event.Without a sample to perform functional evaluation, the root cause cannot be determined.A review of the device history record is not possible.All information reasonably known as of 28 jun 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 sun med 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 sun med holdings llc.Sun med 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 sun med holdings complaint database and identified as complaint comp (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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Product extremely rigid.Causing skin breakdown.No additional information was provided concerning the patients' condition or care.

• Brand Name: SALTER LABS
• Common Device Name: 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
• Report Number: 3000219639-2024-00039
• Device Sequence Number: 20436958
• Product Code: BZD
• UDI-Device Identifier: 10607411007160
• UDI-Public: 10607411007160
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K143700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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
• Operator of Device: Other
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown