MAUDE Adverse Event Report: DEGANIA SILICONE, INC. JP CHAN DRN SIL RND 19FR 3/4 W/TRO; ACCESSORIES, CATHETER

Model Number	JP-2225
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2024
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
Mw5153800: customer reported that jackson-pratt drain was placed in patient monday, following panniculectomy.Patient evaluated with jp tubing amputated at glued portion of tubing and tunneling device consistent with failed/faulty jp drain.Tunneled tubing was embedded into the abdominal wall requiring repeat surgery and removal of foreign body.No other manufacturer jp drain available.Patient was discharged without sequela.
Additional Manufacturer Narrative
Device history record review for batch number p22114003 showed (b)(4) pieces produced 08/22/23, with expiration date of 01/24/2028.A sample was returned for evaluation with a wire tied around the connection point.The supplier¿s in-process control contains tensile strength test of every batch of drains.Testing from retained sample from the same batch passed tensile strength test and the result was compliant within test specification.Based on testing and the information provided, the root cause cannot be determined.

• Brand Name: JP CHAN DRN SIL RND 19FR 3/4 W/TRO
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): DEGANIA SILICONE, INC.; degania bet; 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE, INC.; degania bet; 15130 00; IS 1513000
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19399229
• Report Number: 1423537-2024-00019
• Device Sequence Number: 18217478
• Product Code: KGZ
• UDI-Device Identifier: 10885380182570
• UDI-Public: 10885380182570
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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-2225
• Device Catalogue Number: JP-2225
• Device Lot Number: P22114003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female
• Patient Weight: 83 KG