MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JACKSON PRATT 7MM FLAT DRAIN FULL PERF; CATHETER, IRRIGATION

Model Number	SU130-1310
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A follow up report will be filed.
Event or Problem Description
Customer reported that while removing a jackson pratt drain in order to place a pico dressing on patient¿s right knee, the drain partially broke off inside of the patient¿s knee.There was reportedly little resistance with removal of drain.Patient was taken back to the or to ensure broken pieces were removed.
Additional Manufacturer Narrative
The actual sample was received inside a plastic bag, not in the product's original package.Visual examination showed a piece of what seems as a flat drain attached to a bulb reservoir.The reservoir provided by the customer is not manufactured at cardinal health.The product contains the letters approx.It is not clear if the drain provided was manufactured at cardinal health, since only a portion was returned.Visual inspection of the returned drain portion showed a fracture at the perforated area.Microscopic examination revealed a wavy/jagged edge at the fracture site.Also, a distortion or tear was observed.This observation could suggest that the drain was exposed to excessive force.As no lot number was provided, we were unable to trace the device history record(dhr), quality testing performed and corresponding results.The non-conformance report(ncr) data since january 2019 to present was reviewed and no issues that could be related to the catalog number and condition reported were found.We cannot confirm if the product was manufactured at cardinal health based on the returned unit evaluation.However, we are concluding that the most probable root cause was identified as misuse by the customer.The wavy/jagged edge condition observed at the fracture area suggests excessive force that may have resulted in the breakage.No further action identified at this moment.We will continue to monitor trends and utilize the information as part of continuous improvement.

• Brand Name: JACKSON PRATT 7MM FLAT DRAIN FULL PERF
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 9708502
• Report Number: 1423537-2020-00413
• Device Sequence Number: 3087005
• Product Code: GBX
• UDI-Device Identifier: 10885380064029
• UDI-Public: 10885380064029
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: Health Professional
• Device Model Number: SU130-1310
• Device Catalogue Number: SU130-1310
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/20/2020
• Patient Sequence Number: 1
• Patient Age: 70 YR