MAUDE Adverse Event Report: CAREFUSION, INC PLEURX PLEURAL CATHETER MINI KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number 50-7050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 08/23/2023

Event Type  Injury  

Event Description

Description of the problem (what / why) - at the catheter his abdomen has become inflamed, the patient has been in the hospital for 8 weeks, taken 7 different antibiotics until one took effect.How often did the defect occur - once.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - no.Safety problem - no.Photo / sample available - no.Safety valve broken / damaged / defective - no indication / not applicable.Safety clamp open if valve broken./ damaged./ d.- no indication / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes.Contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - (b)(6) 2023.Where is the catheter located: in the abdomen or chest? - abdomen.Connected device (pleurx/peritx/brand) - 50-70-50.Additional information - individual feedback from patient.Answers: was there a fluid leakage noticed at the catheter site? - not known / no indication.Was there any damage noticed on catheter (cracked or broken) - not known / no indication.

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a24.Patient problem code: f08.

Manufacturer Narrative

(b)(4).Follow-up emdr for device evaluation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001499729 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.There was a deviation at sterilization, but as stated in the deviation form "there is no expected impact on any critical lethality, functionality, packaging integrity or biocompatibility." the load was released, and the documentation is attached in the investigation overview.No issues were reported during the endotoxin testing performed on the pleurx product family.Based on the available information we are not able to identify a root cause at this time.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

Event Description

Description of the problem (what / why) - at the catheter his abdomen has become inflamed, the patient has been in the hospital for 8 weeks, taken 7 different antibiotics until one took effect.How often did the defect occur - once.Medical intervention (other than first aid) - not required.Needle stick/probe stick - not required.Other measures taken - no safety problem - no photo / sample available - no safety valve broken / damaged / defective - no indication / not applicable.Safety clamp open if valve broken./ damaged./ d.- no indication / not applicable.Safety valve lug broken / damaged - no specification / not applicable.Locking tab broken / damaged - no indication / not applicable.Leakage - no indication / not applicable.Successful drainage - yes contact with blood / body fluids - no indication / not applicable.Change in course of treatment due to event - no indication / not applicable.Time spent in catheter - (b)(6) 2023 where is the catheter located: in the abdomen or chest? - abdomen connected device (pleurx/peritx/brand) - 50-70-50 additional information - individual feedback from patient answers: - was there a fluid leakage noticed at the catheter site? - not known / no indication.- was there any damage noticed on catheter (cracked or broken) - not known / no indication.

• Brand Name: PLEURX PLEURAL CATHETER MINI KIT
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17699355
• MDR Text Key: 322846644
• Report Number: 1625685-2023-00087
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 10885403075988
• UDI-Public: (01)10885403075988
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K160450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 50-7050
• Device Lot Number: 0001499729
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other