MAUDE Adverse Event Report: CARDINAL HEALTH P.R. 218, INC. JACKSON PRATT 7MM FLAT DRAIN FULL PERF; CATHETER, IRRIGATION

Model Number	SU130-1310
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A corrective and preventive action (capa) 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 dhr, quality testing performed and corresponding results.An analysis of the complaint data since (b)(6) 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 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.¿ as this is the first complaint received we consider this an isolated incident.
Event or Problem Description
Our customer, (b)(6), received a voicemail messages from an attorney calling on behalf of a female patient of dr.(b)(6)'s office.He indicated the jackson pratt 7mm flat drain full perf catalog number su130-1310 was used on his client prior to the product being recalled and the patient was infected and had spent four days in the hospital.Beyond that, he is not certain what other permanent injuries there may be.The date of incident and patient's age was not provided.This is all the information we have at this time related to this event.

• Brand Name: JACKSON PRATT 7MM FLAT DRAIN FULL PERF
• 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: 6638734
• Report Number: 1423537-2017-00106
• Device Sequence Number: 19094906
• Product Code: GBX
• UDI-Device Identifier: 10885380064029
• UDI-Public: 10885380064029
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/13/2017

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: No Information
• Device Model Number: SU130-1310
• Device Catalogue Number: SU130-1310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 06/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other