MAUDE Adverse Event Report: CAREFUSION, INC SURGIPHOR ANTIMICROBIAL IRRIGATION

Model Number	910100
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two surgiphor bottles cracked while being applied in the operative field.
Additional Manufacturer Narrative
(b)(6) 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: a0404.
Additional Manufacturer Narrative
No samples or photos were available for evaluation.Bd was unable to verify the reported issue or determine a definitive root cause without samples or photos available.This investigation concludes that the combination of the following variables are probable causes that contribute to the failure mode of surgiphor containers cracking during use: aging, bottle wall thickness/bottle weight, inspected product returned into the manufacturing lot, and an upper end of the gamma sterilization dosages of the product.A correction action was opened to investigate the cracked during use issue.The investigation was performed, which included evaluating factors such as manufacturing dates for each process, lots of raw materials used, manufacturing operators, sterilization dosage, and the product's inventory and shipment dates.Additionally, during the manufacturing process at amsino, the filled containers are inspected for leaks using vacuum pressure.After completion of this in-process inspection, the product is released and returned to the manufactured lot.This increased stress may adversely impact the container and may be a contributing factor of the surgiphor container cracking during use failure mode.The product was gamma sterilized at the dosage range between 23.5kgy ¿ 30.2kgy (lot# 1855196) on 21oct2021 per sterigenics certificate of processing.Through the review of current sterilization process, it was determined that the higher end of the validated gamma sterilization range (38kgy) can be reduced to minimize the impact and the physical changes that occur to polypropylene material.The change in the properties of polypropylene is inherent with exposure to higher dosages of gamma irradiation and may be a probable cause for the cracking during use.No further actions are required.This failure mode will continue to be tracked and trended.H3 other text: see narrative below.
Event or Problem Description
Two surgiphor bottles cracked while being applied in the operative field.

• Brand Name: SURGIPHOR ANTIMICROBIAL IRRIGATION
• Common Device Name: SURGIPHOR ANTIMICROBIAL IRRIGATION
• 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: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 16949895
• Report Number: 1423507-2023-00089
• Device Sequence Number: 3466779
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 04/28/2023
• Device Model Number: 910100
• Device Catalogue Number: 910100
• Device Lot Number: 1855196
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2021
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown