MAUDE Adverse Event Report: CARDINAL HEALTH P.R. 218, INC. JP HEMADUCT 19FR W/15FR TROCAR; CATHETER, IRRIGATION

Model Number	JP-HUR195
Health Effect - Clinical Codes	Abdominal Pain (1685); Fever (1858); Unspecified Infection (1930)
Date of Event	12/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is on-going.A follow-up report will filed once investigation has been completed.
Event or Problem Description
Customer has reported that the patient allegedly developed an infection after having a jackson pratt drain placed.Customer reports that a female patient age 39 had a jackson pratt drain placed following an abdominal plastic procedure.Drain was placed on (b)(6) 2016 and removed on (b)(6) 2016 and the patient returned to the hospital due to abdominal pain and a fever.Patient was hospitalized and the drain was removed and a new drain placed on (b)(6)2016.Patient was given antibiotics due to a staph infection.Facility does not track lot number and is reporting product was either product number su130-1411 or jp-hur195.
Additional Manufacturer Narrative
A corrective and preventive action was initiated for the issue and recall issued prior to this complaint being logged.The customer sample was not available for evaluation.It is vital to the investigation that the customer sample or lot number be available for review and testing.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 june 2016 to present was reviewed and demonstrates that this is the first time that this type of issue is reported from this catalog in the last 12 months.A root cause for the reported concern cannot be identified with the amount of information available.The allegedly defective sample was not returned for evaluation.No actions identified, since no evidence of a manufacturing issue was found.It is important to ensure that product is used per instructions provided in the directions for use that states the following: ¿trocars, drains and reservoirs are for single patient use only and should be discarded after use. do not use if package has been opened or damaged.Risk associated with the use of wound drains include, but are not limited to, infection and inflammation.Prior to surgery, the patient should be informed of the risk or complications arising from the patient¿s degree of intolerance to any foreign object placed in the body.¿ the investigation and 100% inspection of 22,000 units from inventory showed that the potential for a failed sterility (tested via industry standard dye testing) is very low at 0.23% of product produced.Based on the information provided, it cannot be confirmed that the infection experienced was caused by or related to this product.

• Brand Name: JP HEMADUCT 19FR W/15FR TROCAR
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH P.R. 218, INC.; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 6675244
• Report Number: 1423537-2017-00111
• Device Sequence Number: 19347720
• Product Code: GBX
• UDI-Device Identifier: 10885380064135
• UDI-Public: 10885380064135
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

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: JP-HUR195
• Device Catalogue Number: JP-HUR195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/30/2017
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/28/2017
• Supplement Report FDA Received Date: 07/21/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 39 YR