MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO 15FR SILICONE DRAIN WITH TROCAR; CATHETER, IRRIGATION

Model Number	SU130-0323
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the wound drain was found fractured in the middle during a breast surgery and was replaced during that initial surgery.The product was connected with su130-1305 100cc reservoir to process wound drain.No patient injury was reported.
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
A sample was received inside of a plastic bag, not in its original package, for investigation.It appears that when the drain broke there was a portion of the length of the drain that was discarded and not returned for evaluation.The drain was manufactured by cardinal health, however, the reservoir returned along with the drain sample was a non-cardinal health product.Visual inspection revealed a jagged edge at the fracture of the tubing site.No indications of stretched tube were observed.The characteristics of the fractured suggests that an instrument was used to handle the product.The drain included a thread that appears to be a suture attached to the drain tube.Per the ifu (instructions for use), for alternate connections the following is instructed: to connect any jackson-pratt drain with any non-jackson-pratt reservoir; fit end of su130-1340 to the outflow of drain.Connect end b to the reservoir inlet port; the reservoir used must accept a 6mm (1/4¿) male connector.Additionally, the ifu indicates that drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.Also, to facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).The most probable root cause was identified as misuse by the customer since the jagged edge condition observed at the fracture area suggests that an instrument was used to handle the product which may have inadvertently damage the product thus leading to tubing breakage.As per instructions for use establishes, the drains cannot be suture.Any suture in the drain could lead to drain breakage.In addition, the instruction for use establishes that drain to be used with any non-jackson-pratt reservoir must be used with a connector.As preventive action, customer will be provided with a copy of the ifu.The device history record (dhr) for this lot number was manufactured and released in compliance with all requirements.We will continue to monitor trends and utilize the information as part of continuous improvement.

• Brand Name: 15FR SILICONE DRAIN WITH TROCAR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 19397762
• Report Number: 1423537-2024-00018
• Device Sequence Number: 7800185
• Product Code: GBX
• UDI-Device Identifier: 10192253022247
• UDI-Public: 10192253022247
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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 Model Number: SU130-0323
• Device Catalogue Number: SU130-0323
• Device Lot Number: 1211452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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: 05/24/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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
• Patient Sex: Unknown