MAUDE Adverse Event Report: CARDINAL HEALTH P.R. 218, INC. DRAIN JACKSON PRATT 10FR 7MM; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-0321
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer sample was received for investigation.Visual examination of the returned sample showed that it is 1.09 inches in length portion of jackson-pratt silicone round drain 10fr.Visual inspection revealed that the silicone tubing broke off at perforated 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 those failures, which are caused by puncture by a sharp instrument on the tubing surface.As no lot number was provided, we were unable to trace the device history record, quality testing performed and corresponding results.An analysis of the complaint data since nov.2015 to present demonstrates that this is the first time that this type of issue is reported from this catalog, although (b)(4) incidents for the same condition from other catalogs were reported.The ncr data was also reviewed for the same time period and no issue that could be related to the condition reported were found.It is highly recommended that lot number are documented in patient medical record as reference for further investigation.  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 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.¿.
Event or Problem Description
On (b)(6) 2016, patient underwent total right knee replacement surgery.Jackson-pratt drain was inserted to the wound without anchoring during surgery.On (b)(6) 2016, during follow up and in routine x-ray, an opaque oblique line at the infrapatellar region was found.Operation was arranged for removal of foreign body from right knee the same day.A broken drain was found at retropatellar region and removed uneventfully.

• Brand Name: DRAIN JACKSON PRATT 10FR 7MM
• 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: 6080132
• Report Number: 1423537-2016-00055
• Device Sequence Number: 11002591
• Product Code: GCY
• UDI-Device Identifier: 10885380063985
• UDI-Public: 10885380063985
• 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
• Report Date (Section B): 11/04/2016

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: SU130-0321
• Device Catalogue Number: SU130-0321
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Distributor Facility Aware Date: 10/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 11/04/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention