MAUDE Adverse Event Report: CAREFUSION, INC PERITX PERITONEAL CATHETER & STARTER KIT; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number	50-9900C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that sheath tore off when it was removed from the wire.Verbatim: i just wanted to reach out and let you know that we had an issue with the peritx kit sheath that we haven't experience before.The needle/sheath that is used to get access and pass the wire tore off when it was removed from the wire so we could place the dilators.Additional information received 10-feb-2023.The date of the exam was (b)(6) 2023.The needle itself was not broken but the sheath that covers the needle that is used to pass the jwire was intact when the case started but it broke when it was removed from the wire.The issue happened during the exam it was used on the patient, we tried to remove the piece of the sheath but we were unable to locate it.It was located in the right side of the abdomen i do have a photo of the broken sheath but i do not have it to send back for evaluation.
Additional Manufacturer Narrative
Pr initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0414.Patient problem code: f26.
Additional 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 0001478732 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.Based on the available information we are not able to identify a root cause at this time.Manufacturing personnel have been notified of this incident and awareness training was provided.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 or Problem Description
It was reported by the customer that sheath tore off when it was removed from the wire.Verbatim: i just wanted to reach out and let you know that we had an issue with the peritx kit sheath that we haven't experience before.The needle/sheath that is used to get access and pass the wire tore off when it was removed from the wire so we could place the dilators.The date of the exam was (b)(6) 2023.The needle itself was not broken but the sheath that covers the needle that is used to pass the jwire was intact when the case started but it broke when it was removed from the wire.The issue happened during the exam.It was used on the patient, we tried to remove the piece of the sheath but we were unable to locate it.It was located in the right side of the abdomen.I do have a photo of the broken sheath but i do not have it to send back for evaluation.

• Brand Name: PERITX PERITONEAL CATHETER & STARTER KIT
• Common Device Name: 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: 16378837
• Report Number: 1625685-2023-00025
• Device Sequence Number: 12202208
• Product Code: PNG
• UDI-Device Identifier: 10885403501838
• UDI-Public: (01)10885403501838
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K201155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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: 04/30/2023
• Device Model Number: 50-9900C
• Device Catalogue Number: 50-9900C
• Device Lot Number: 0001478732
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown