MAUDE Adverse Event Report: CARDINAL HEALTH P.R. 218, INC. DRAIN JACKSON PRATT 15FR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-0323
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint investigation is on-going.Sample received by cardinal health on 12/6/16, once the investigation is completed a  follow up report will be filed.
Event or Problem Description
(b)(4).Patient had surgery.Surgeon placed a round 15 french silicon drain produced by cardinal health in the axilla.Patient was seen in the office.When drain was removed, it tore and the majority was left in the patient.Patient had residual drain removed six days later.The patient tolerated the removal of the remaining portion of the drain well with no complications.There was no suture or other obvious mechanical reason to explain why the drain tore.Per quality chart review, this patient did not experience serious injury as a result of the incomplete removal of the device during the initial post-operative attempt to remove.
Additional Manufacturer Narrative
The customer sample was received inside of plastic bag, not its original package.Visual examination showed that it is 15fr round silicone drain and it was attached to a jp100cc suction reservoir.It also showed traces of dried body fluid inside the drain/reservoir and a piece of black suture thread attached to the tubing at approximately 2.04 inches from the fracture site.The perforated drain section had not failed.The unperforated tubing section was in two pieces.Visual inspection revealed that the silicone tubing broke off at approximately 3.00 inches from the perforated drain area.Microscopic examination revealed wavy/jagged edge at the tubing fracture site and no distortion and/or tears in the adjacent portion drain, 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 failures caused by abrasion or scoring with a sharp instrument on the tubing surface.As no lot number was provided, we were unable to trace the dhr, quality testing performed and corresponding results.An analysis of the complaint data since dec.2015 to present demonstrates that this is the second time that this type of issue is reported from this catalog.The ncr data was also reviewed for the same time period and no issue that could be related to the condition reported were found.  the most probable root cause was identified 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 inadvertently damage 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.According to the instructions for use (ifu). ¿drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.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).Drains should be placed and removed carefully by hand only with a slow, steady pressure.Excessive force may result in breakage.During placement and removal of the drain, do not nick, cut, tear or otherwise damage the drain as this may lead to breakage.Leaving the drain implanted for any period of time which allows for tissue ingrowth around the drain and into the holes, may cause breakage on removal.¿.

• Brand Name: DRAIN JACKSON PRATT 15FR
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH P.R. 218, INC.; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 6159556
• Report Number: 1423537-2016-00064
• Device Sequence Number: 970739
• Product Code: GCY
• UDI-Device Identifier: 10885380063992
• UDI-Public: 10885380063992
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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: Physician
• Device Model Number: SU130-0323
• Device Catalogue Number: SU130-0323
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Distributor Facility Aware Date: 11/15/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 02/06/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR