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

Model Number JP-HUR195

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Pain (1994)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

The investigation is on-going.A follow-up report will filed once investigation has been completed.

Event 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 (b)(6) had a jackson pratt drain placed following an abdominal plasti procedure.Drain was placed on (b)(6) 2017 and removed on (b)(6) 2017 and patient had a fever and back pain and was found to have a staph infection and was hospitalized.Facility does not track lot number and is reporting product was either product number su130-1411 or jp-hur195.

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 report, quality testing performed and corresponding results.An analysis of the complaint data since july 2016 to present was reviewed and demonstrates that this is the third 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 (b)(4) units from inventory showed that the potential for a failed sterility (tested via industry standard dye testing) is very low at (b)(4)% 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
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH P.R. 218, INC.; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): CARDINAL HEALTH P.R. 218, INC.; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 6675272
• MDR Text Key: 78653719
• Report Number: 1423537-2017-00112
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10885380064135
• UDI-Public: 10885380064135
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: JP-HUR195
• Device Catalogue Number: JP-HUR195
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/30/2017
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 48 YR