MAUDE Adverse Event Report: CARDINAL HEALTH P.R. 218, INC. DRAIN JACKSON PRATT 10FR 1/8END; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number	SU130-1321
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forwarded on to the manufacturing facility for investigation.The sample was received on 1/12/17.The results of the investigation are pending, a follow up report will be submitted once the investigation has been completed.
Event or Problem Description
On (b)(6) 2016 a drain tube was placed in patient¿s wound after spinal procedure. five days later during removal, part of the drain tube broke off inside patient and patient required emergency procedure to remove tubing.
Additional Manufacturer Narrative
The customer sample was received inside of plastic bag, not its original package.Visual examination showed that it is 3.03 inches in length portion of silicone round drain 10fr.Visual inspection revealed that the silicone tubing broke off at unperforated tubing section.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.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 835 psi in testing performed.The minimum pull test specification for this drain is 3.0 lb.Dhr demonstrated pull test results of a minimum of 5.0 lb in the perforated area in quality testing performed.Inspection record for the raw material used to extrude the tubing was reviewed and certificate of analysis (coa) indicates that all test results were within specification limits, including tensile and tear tests.This is the first complaint received on this catalog in the last 12 months.The lot number reported was manufactured on march 23, 2015.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 10FR 1/8END
• Common Device Name: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH P.R. 218, INC.; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 6262483
• Report Number: 1423537-2017-00067
• Device Sequence Number: 426034
• Product Code: GCX
• UDI-Device Identifier: 10885380064050
• UDI-Public: 10885380064050
• 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,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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: SU130-1321
• Device Catalogue Number: SU130-1321
• Device Lot Number: 1150256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Distributor Facility Aware Date: 12/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR