MAUDE Adverse Event Report: Sunmed CARDINAL HEALTH; Breathing Bag

Model Number	BB3000LFB
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: CARDINAL HEALTH
• Common Device Name: Breathing Bag
• Manufacturer (Section D): Sunmed; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V; cerrada via de la produccion; no.85 parque indust; mexicali iii, mx 21397 ; MX 21397
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 50509952
• Report Number: 1314417-2026-00054
• Device Sequence Number: 13142126
• Product Code: BTC
• UDI-Device Identifier: 50885380208421
• UDI-Public: (01)50885380208421
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BB3000LFB
• Device Catalogue Number: BB3000LFB
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/29/2026
• Supplement Report FDA Received Date: 09/25/2026
• 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