MAUDE Adverse Event Report: CAREFUSION, INC SURGIPHOR ANTIMICROBIAL IRRIGATION

Model Number 910100

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2023

Event Type  malfunction  

Event Description

Two surgiphor bottles cracked while being applied in the operative field.

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.

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 Description

Two surgiphor bottles cracked while being applied in the operative field.

• Brand Name: SURGIPHOR ANTIMICROBIAL IRRIGATION
• Type of Device: 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
• MDR Text Key: 315422965
• Report Number: 1423507-2023-00089
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00382909101003
• UDI-Public: (01)00382909101003
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K202071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2021
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other