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

Model Number	910100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer stated that a couple patients got an infection after using surgiphor.Spine doctor was operating on the patient and is not known to have infections according to the customer and she states that the patient got an infection and the only thing changed was the addition of surgiphor.
Additional Manufacturer Narrative
(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.H3 : no photos or samples are available.
Additional Manufacturer Narrative
Pr (b)(4) supplemental mdr.No photos or samples were received by our quality team for evaluation.Therefore, the reported failure could not be confirmed.A device history record review found no non-conformances associated with this issue during production of this batch.The sterilization records were reviewed, and no abnormalities were observed.Based on the quality team's investigation, the root cause of this incident cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.--- section d.2b procode: fqh (lavage, jet) and fro (dressing, wound, drug) h3 other text : see narrative below.
Event or Problem Description
Customer stated that patient got an infection after using surgiphor.Spine doctor was operating on the patient and is not known to have infections according to the customer and she states that the patient got an infection and the only thing changed was the addition of surgiphor.

• Brand Name: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Common Device Name: SUGIPHOR
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17312844
• Report Number: 1423507-2023-00093
• Device Sequence Number: 7157941
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2023
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1862097
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 10 YR
• Patient Sex: Female
• Patient Weight: 29 KG
• Patient Ethnicity: Hispanic
• Patient Race: White