MAUDE Adverse Event Report: DEGANIA SILICONE, INC. JP CHAN DRN SIL HUBLESS 15FR W/TRO; ACCESSORIES, CATHETER

Model Number	JP-2229
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Event or Problem Description
Mw (b)(4) : the pa (physician¿s assistant) carefully removed the suture first, noting the tubing was not cut, made sure to let out all suction before removing.As drain was being removed, slight typical resistance, believed to be the slightly larger portion of the drain was noted.Tubing was coming out as intended and then upon examination, the drain was noted to have a frayed edge.Pa immediately escalated to attending who assessed area and ordered a ct to evaluate retained drain.Patient underwent incision and removal of the retained foreign body.Procedure was completed without complications and the patient was discharged home.To remove the retained foreign body, patient underwent 2cm proximal and distal incisions then the entire incision was opened as the drain was not easily identified followed by removal of the retained foreign body (rfb) under monitored anesthesia care (mac).
Additional Manufacturer Narrative
Device history record review: batch p22113899 ((b)(4) pcs., prod.Date 22/02/23, exp.Date 22/02/28).Our in-process control includes a tensile strength test for every batch of the drains.Batch p22113899 passed the tensile strength test (tear test) in both the tube part and the fluted part.According to our quality process, the minimum requirement for both tests is fmin = 55n, while the standard requires only f=15n.The results for this batch were as follows: tube part: faverage = 139n fluted part: faverage = 114n our products exhibit a very high tensile strength, which suggests that normal forces are unlikely to cause breakage.A retained sample from the same batch was inspected and found compliant with specification.A sample was not returned and a photo not provided, therefore, this complaint could not be confirmed.No new actions will be taken.If additional information is received, this complaint will be reopened.

• Brand Name: JP CHAN DRN SIL HUBLESS 15FR W/TRO
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): DEGANIA SILICONE, INC.; degania bet; 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA; degania bet; 15130 00; IS 1513000
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19812391
• Report Number: 1423537-2024-00082
• Device Sequence Number: 8379792
• Product Code: KGZ
• UDI-Device Identifier: 10885380182617
• UDI-Public: 10885380182617
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: JP-2229
• Device Catalogue Number: JP-2229
• Device Lot Number: P22113899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/25/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 127 KG