MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO DRAIN JACKSONPRATT FL7MM3/4 PE; CATHETER, IRRIGATION

Model Number SU130-1308

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

Patient Problem Discomfort (2330)

Event Date 07/14/2018

Event Type  malfunction  

Manufacturer Narrative

The customer sample was not returned for evaluation.It is vital to the investigation that the customer sample be returned for examination and testing.If the sample becomes available, it can be forwarded to us so further evaluation can be performed.Although the customer sample was not available for evaluation, pictures of the device were sent for review.The pictures showed a piece of white section of flat 7 mm drain.Upon evaluation of the pictures it was noticed that the fracture occurred at the perforated area.The pictures showed a wavy/jagged edge at the fracture site.The characteristics of the fracture are similar to those failures, which are caused by some abrasion or scoring with sharp instruments on the drain surface.No lot number was provided; therefore, we were unable to trace the dhr, quality testing performed and corresponding results.The non-conformance report(ncr) data since dec 2017 to present was reviewed and no issues that could be related to the catalog number and condition reported were found.Root cause for the reported condition cannot be identified with the amount of information available.As preventive actions, the customer will be provided with a copy of the instructions for use.It is recommended to strictly follow the instructions provided in the instruction for use (ifu) data included with the product to ensure drains are properly used.According to the instructions for use (ifu).¿drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.To facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).Drains should be placed and removed carefully by hand only with a slow, steady pressure.Excessive force may result in breakage.During placement and removal of the drain, do not nick, cut, tear or otherwise damage the drain as this may lead to breakage.Leaving the drain implanted for any period of time which allows for tissue ingrowth around the drain and into the holes, may cause breakage on removal.¿ we will continue to monitor trends and utilize the information as part of continuous improvement.[(b)(4)].

Event Description

During surgery for removal of instrumentation, facet fusion, transforaminal lumbar inter body fusion l3-s1, the surgeon placed two flat 7mm jackson pratt drains.One was placed 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 without resistance and it 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.A decision was made 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 immediately stopped using these drains.

• Brand Name: DRAIN JACKSONPRATT FL7MM3/4 PE
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085
• MDR Report Key: 8170882
• MDR Text Key: 131795488
• Report Number: 1423537-2018-00247
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10885380064005
• UDI-Public: 10885380064005
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

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
• Device Operator: Health Professional
• Device Model Number: SU130-1308
• Device Catalogue Number: SU130-1308
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/17/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 86