MAUDE Adverse Event Report: SALTER LABS SALTER LABS; CANNULAIDE SIZE 2, FOR BABIES 1250G-2000G, 25 PER B

Model Number	CA102-0-25
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, due to the increased rigidity, the new velcro caused (unspecified) trauma to the baby.No additional information provided concerning medical intervention and/or patient outcome.Additional information received, 11mar2026 reported, the patient outcome was the skin redness potentialy progressed to stage 2 skin injury, worse than prior redness.No additional information provided concerning medical intervention and/or patient outcome.
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2026 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-(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.

• Brand Name: SALTER LABS
• Common Device Name: CANNULAIDE SIZE 2, FOR BABIES 1250G-2000G, 25 PER B
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• Manufacturer (Section G): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx 32596 ; MX 32596
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 24683076
• Report Number: 3004748541-2026-00056
• Device Sequence Number: 13265513
• Product Code: BZD
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: Health Professional
• Device Model Number: CA102-0-25
• Device Catalogue Number: CA102-0-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 07/09/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown