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

Model Number	SU130-1311
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not available for evaluation.It is vital to the investigation that the actual device be available for review and testing.The non-conformance report data was reviewed and no issues related to this complaint were found.The device history record (dhr) for the lot number reported was reviewed and no incident was documented.An analysis of the complaint trends demonstrates that this is the second time that we have received this type of report for the catalog number in the last 12 months.The customer did not return the actual sample.Based on the dhr and without the actual sample, the root cause for the reported concern cannot be identified.It is important to ensure that product is used per instructions provided in the directions for use.Risk associated with the use of wound drains include, but are not limited to, infection and inflammation.No corrective action will be taken at this time, but we will continue to monitor trends and utilize the information as part of continuous improvement.
Event or Problem Description
Customer reported that during procedure wound drain was placed in patient following the removal of a large lesion from abdomen.It was reported that the patient allegedly developed an infection and the drain was pulled.Customer further reported they have never had infections and are not certain if drain is the cause for this patient.

• Brand Name: JACKSON PRATT 10MM FLAT DRAIN FULL PERF
• 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: 6777412
• Report Number: 1423537-2017-00118
• Device Sequence Number: 11166746
• Product Code: GCY
• UDI-Device Identifier: 10885380064036
• UDI-Public: 10885380064036
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 08/09/2017

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
• Operator of Device: Physician
• Device Model Number: SU130-1311
• Device Catalogue Number: SU130-1311
• Device Lot Number: 1161096
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/09/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention