MAUDE Adverse Event Report: CARDINAL HEALTH KIT DRAIN 100CC W/7MM PERF

Model Number SU130-1360

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

The patient underwent an open cholecystectomy and a jackson-pratt drain was placed.Three days later the surgery resident tried removing the drain prior to discharge.First, he released the negative pressure, cut the anchor and twisted the drain to ensure that it was free, but it did not move.The resident tried pulling the drain again and it snapped off in the patient.He immediately informed the surgeon and the patient was scheduled for localization of the drain radiographically: first by ultrasound and then by fluoroscopy.The remnant of the drain was found intraperitoneally and it was decided that the patient needed to undergo an "emergency removal of foreign body".He was brought to the operating room where the previous incision was reopened, the drain removed and the wound sutured close again.

Manufacturer Narrative

The complaint and sample have been forwarded to the manufacturing facility for investigation.Once their investigation is completed, a follow-up report will be filed.

Manufacturer Narrative

(b)(4).The actual customer sample was received inside of plastic bag, not its original package.Visual examination showed that it is a jp 7mm flat drain full perforated.The molded white flat drain section showed no damage.It also showed traces of dried body fluid inside the drain.Visual inspection revealed that the clear silicone tubing broke at approximately 1.08 inches from the drain/tubing junction area.Microscopic examination revealed wavy/jagged edge at the fracture site and no tubing distortion in the failure area, which suggests that the drain was not stretched (elongated) to failure.The characteristics of the fractured area and the absence of any tubing distortion are similar to those failures, which are caused by puncture by a sharp instrument or any other inadequate tubing handling practice such as but not limited to twist, warp, pinch, etc.Another observation in the clear silicone tubing showed a cut most probably caused by a sharp instrument just at the fracture site.The device history record (dhr) for the finished good was reviewed and no incident was documented that could have caused this type of non-conformance.No reported non-conformances were found from review of the records, which included incoming and in-process inspection, non-conforming reports and manufacturing records.The minimum tensile strength specification for the tubing is 750 psi.Dhr of this tubing demonstrated tensile strength results of a minimum of 889 psi in testing performed.Inspection records for raw material used to extrude the clear tubing, where the fracture occurred, were reviewed and certificate of analysis (coa) indicates that all test results are within specification limits, including tensile and tear tests.The most probable root cause can be attributed as misuse by the customer since the wavy/jagged edge condition observed at the fracture area suggests that an instrument was used to handle the product which may have damage the product or customer did not properly handle the product thus leading to tubing breakage.It is also recommended to strictly follow the instructions provided in the instruction for use data included with the product to ensure drains are properly used.See attachment for instruction for use.

• Brand Name: KIT DRAIN 100CC W/7MM PERF
• Type of Device: DRAIN
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL
• Manufacturer (Section G): CARDINAL HEALTH P.R. 218, INC; state rd. 402,km 0.9; anasco PR 00610
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 4906425
• MDR Text Key: 6029912
• Report Number: 1423537-2015-00046
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2015

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
• Device Operator: Physician
• Device Model Number: SU130-1360
• Device Catalogue Number: SU130-1360
• Device Lot Number: 1140082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention