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

Catalog Number	910100
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
02oct2023: (b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Imdrf annex e code health effect ¿ clinical code: e2403.Imdrf annex a code medical device problem code: a180305.
Event or Problem Description
Verbatim: rcc received the complaint via email.Email as attached.This is to notify you that we have a potential solution sterility failure in two commercial lots of surgiphor/surgirinse irrigation systems (lot no.1817359/ expiration date february 2023 / part number 910100 and lot no.1817360 / expiration date february 2023 / part no.910100) discovered today.The testing corresponds with product at the end of shelf-life (t = 24 months) which has been stored under ich zone ii conditions (25°c / 60% rh).This is the only stability condition tested for this product.These two lots entered the stability program in calendar year 2021 via stability protocol 2021-hp023-pq and were sent to nelsons laboratory to conduct the sterility testing at t= 24 months.Sterility testing is only performed at t=0 and t=24 months.Nelsons lab will start a formal investigation to determine if the failure is truly representative of the microbial characteristics of the product or if the results is derived from a laboratory error.As per our local stability procedures at bd el paso (0804-003-000-swi-ep commercial finished product stability testing, section 5.1.9 ), we need to notify you of the potential failure with these lots so you can decide if this event requires a communication to the fda via a filed alert (far).Please let us know if you need additional information from this end for purposes of completing your review.
Event or Problem Description
This is to notify you that we have a potential solution sterility failure in two commercial lots of surgiphor/surgirinse irrigation systems (lot no.1817359/ expiration date february 2023 / part number 910100 and lot no.1817360 / expiration date february 2023 / part no.910100) discovered today.The testing corresponds with product at the end of shelf-life (t = 24 months) which has been stored under ich zone ii conditions (25°c / 60% rh).This is the only stability condition tested for this product.These two lots entered the stability program in calendar year 2021 via stability protocol (b)(4) and were sent to nelsons laboratory to conduct the sterility testing at t= 24 months.Sterility testing is only performed at t=0 and t=24 months.Nelsons lab will start a formal investigation to determine if the failure is truly representative of the microbial characteristics of the product or if the results is derived from a laboratory error.As per our local stability procedures at bd el paso (0804-003-000-swi-ep commercial finished product stability testing, section 5.1.9 ), we need to notify you of the potential failure with these lots so you can decide if this event requires a communication to the fda via a filed alert (far).Please let us know if you need additional information from this end for purposes of completing your review.
Additional Manufacturer Narrative
Quality notifications (qn-2001111536 / qn-201115367) were completed for product code 910100 bd surgiphor-surgirinse lots 1817359 and 1817360.The purpose of these quality notifications is to provide documented evidence associated with a solution sterility failure at the end of shelf-life (t=24 months/zone ii).The testing of solution sterility was performed on august 22, 2023, at a contract laboratory nelson (itasca, il).A thorough investigation outlined in quality notifications concluded that there was no evidence during the manufacturing process of these lots that could have contributed to the sterility failure.Based on this investigation it was concluded that the most probable root cause for the testing result (suspect contamination) was an external influence during the execution of the sterility testing at nelson laboratories.A solution sterility re-test was conducted at nelson on november 18, 2023, and the solution sterility results obtained showed no microbial growth.Testing confirmed the solutions for these lots remained sterile at end of shelf-life.H3 other text : see narrative below.

• Brand Name: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Common Device Name: BD SURGIPHOR¿ STERILE WOUND IRRIGATION SYSTEM
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• Manufacturer Contact: andrew topoulos ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17851790
• Report Number: 1423507-2023-00101
• Device Sequence Number: 3453592
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 01/18/2024

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: Other
• Device Expiration Date: 02/03/2023
• Device Catalogue Number: 910100
• Device Lot Number: 1817360
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown