MAUDE Adverse Event Report: CARDINAL HEALTH 200, INC. JACKSON PRATT DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Catalog Number SU131308

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2018

Event Type  Injury  

Event Description

During surgery for removal of instrumentation, facet fusion, transforaminal lumbar interbody fusion l3-s1, the surgeon placed 2 flat 7mm jackson pratt drains.One on the left and one on the right through separate stab incisions.Muscle and fascia were approximated using interrupted vicryl sutures.Skin staples and skin glue were used to approximate the skin.The next day, the surgeon removed the left drain with out resistance and was noted to be intact.During removal of the right drain the surgeon noted that there was no resistance, but that the drain was tearing at one of the perforations.The surgeon attempted to grab the drain piece that was tearing with a hemostat to ensure entire removal, but this was to uncomfortable for the patient.The decision was to cut the drain and return the patient for surgical removal of the retained drain piece.The patient was brought back to surgery where the incision was re-opened and the entire drain was removed and examined.There was an obvious fracture through the perforation at the proximal end of the drain.The patient recovered without incident.No permanent harm to the patient.The surgeon has immediately stopped using these drains.

• Brand Name: JACKSON PRATT DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7826497
• MDR Text Key: 118572446
• Report Number: 7826497
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SU131308
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 27010 DA
• Patient Weight: 86