MAUDE Adverse Event Report: DEGANIA SILICONE LTD JACKSON-PRATT CHANNEL DRAIN; SILICONE FLUTED 15FR DRAIN

Model Number UNKNOWN

Device Problem Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

On 05/16/2019 we received the report from our customer (distributor of the device) of the drain with below description: "while exploring a deep left ischial decubitus ulcer, the surgeon discovered a fragment (4 1/2") of what appeared to be a 15f blake drain.It was removed, noted to be 8cm long, no other drain fragments found.It appears to be jackson pratt drain.Supplier: degania" the hospital discarded the item; the part number and the lot number of this drain is unknown, however the customer states that this is 15fr jackson pratt drain of degania.Degania remarks: since the piece of drain found inside the patient reported to be 4 1/2" long, we conclude that the event is actually tear in use: part of white fluted drain tore and left inside the patient.The tear did not happen in connection area, as otherwise the torn fragment should be at least 30 cm long.Degania supplies to this customer two part numbers of 15 fr jackson pratt drains (one with trocar and the other without trocar).If the broken part indeed is degania's product, the possible part numbers can be jp-2188 or p-2189.We checked the tensile test results (tear in tube-profile connection) of the recent production lot p1868563 of jp-2188 (11003801580cr).For this lot, the min.Result is 77.24n and the average result is 94,77n.This result is much higher than the 15n min.Required by the iso standard en1617, section 4.3.1."force at break - connections".The production control of the possible part numbers include 100% visual inspection for any damage which could lead to tear.This is silicone drain, and the property of silicone material is easy breakage (tear) in the area of slight cut or nick.Our conclusion is that most likely the drain tore following some damage in use.

Event Description

While exploring a deep left ischial decubitus ulcer, the surgeon discovered a fragment (4 1/2") of what appeared to be a 15f blake drain.It was removed, noted to be 8cm long, no other drain fragments found.It appears to be jackson pratt drain.Supplier: (b)(6).

• Brand Name: JACKSON-PRATT CHANNEL DRAIN
• Type of Device: SILICONE FLUTED 15FR DRAIN
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; jordan valley; degania bet, 15130 00; IS 1513000
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; degania bet, 15130 00; IS 1513000
• Manufacturer Contact: katia kayam ; degania bet; degania bet, jordan valley 15130-00 ; IS 1513000
• MDR Report Key: 8682168
• MDR Text Key: 204628017
• Report Number: 8030107-2019-00009
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention