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	Insufficient Information (4580)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that the product was placed early last week.Patient went to another unit and the drain wasn¿t producing anything.The doctor assumed it was just the bulb that was the issue, so she replaced the bulb.Nothing resulted from this.It turned out there was an air leak which caused the drain to have no suction.When the doctor went to manipulate the actual drain line it fell apart and completely pulled out with the suture attached to the end.No further information provided.
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.
Additional Manufacturer Narrative
Actual sample was not available for evaluation, therefore the root cause for the drain breakage could not be confirmed.The batch p22114004 (4000 pcs., prod.Date 15/05/23, exp.Date 15/05/28), successfully passed sampling size sufficiency test to ensure that the drains are functioning properly.Supplier¿s in-process control includes tensile strength test of every batch of the drains.The batch passed the tensile strength test (tear test) in the connection area.All the results were higher than minimum requirement according to the test specification.The drain may have been punctured by a sharp object during use, resulting in a small cut that led to leakage.Subsequently, when the doctor manipulated the drain, the cut may have spread along its length, most likely the drain failed due to some damage in use.One of the properties of silicone drains is to snap easily in place of even slight cut or nick.

• 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: 19055688
• Report Number: 1423537-2024-00014
• Device Sequence Number: 15288488
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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: P22114004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/11/2024
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 04/29/2024
• Date Device Manufactured: 05/15/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown