MAUDE Adverse Event Report: CAREFUSION, INC BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM

Catalog Number	910110
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the surgiphor bottle cracked during use.There was no patient harm reported.Note, the date of event (15-nov-2025) is considered to be a best estimate.Section c.1a name and strength: 0.5% povidone iodine (pvp-i) in phosphate-buffered saline, potassium iodide, and vitamin e tpgs.Section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug).Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
Per medsun report (b)(4): "no harm to patient.When using the surgiphor antimicrobial irrigation system (ref #910110, lot # 4297341, exp date 09-30-2026), the bottle cracked while in surgeon's hand being used as directed.The wound was irrigated with large amount of sterile fluid and bottle inspected with all pieces intact.".
Additional Manufacturer Narrative
It was reported that the surgiphor bottle cracked during use.There was no patient harm reported.Note, the date of event (15-nov-2025) is considered to be a best estimate.Section c.1a name and strength: 0.5% povidone iodine (pvp-i) in phosphate-buffered saline, potassium iodide, and vitamin e tpgs.Section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug).Addendum: this supplemental mdr is submitted to document the results of investigation performed to analyze the root cause.Based on the information available and without having the photos or sample to evaluate, no conclusions can be made.A device history record review found no non-conformance's associated with this issue during production of the reported batch.Additionally, retain samples were inspected and found no visible abnormalities or signs of the reported cracking on the bottle.A capa was opened to investigate events of this nature.Complaints are monitored and reviewed for emerging trends.Updated fields: b4, g3, g6, h2, h6, h10.Note: section a through f - the information provided by bd 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 bd.
Event or Problem Description
Per medsun report: (b)(4): "no harm to patient.When using the surgiphor antimicrobial irrigation system (ref#: 910110, lot#: 4297341, exp date: 09-30-2026), the bottle cracked while in surgeon's hand being used as directed.The wound was irrigated with large amount of sterile fluid and bottle inspected with all pieces intact.".

• Brand Name: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Common Device Name: SURGIPHOR
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: andrew topoulos ; 75 north fairway drive; vernon hills, IL 60061 ; 8003239088
• MDR Report Key: 24148991
• Report Number: 1423507-2026-00010
• Device Sequence Number: 8841176
• Product Code: FQH
• UDI-Device Identifier: 00382909101102
• UDI-Public: (01)00382909101102(17)260930(10)4297341
• Combination Product (Y/N): Y
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K221504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 910110
• Device Lot Number: 4297341
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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
• Patient Age: 38 YR
• Patient Sex: Female