MAUDE Adverse Event Report: DEGANIA SILICONE LTD JACKSON-PRATT CHANNEL DRAIN; FLAT FLUTED DRAIN, 10 MM

Model Number 10 MM

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017 the customer reported: "(b)(6) old female had first post-op clinic visit.During attempt to remove two jp drains, they snapped off and portion remained in patient.Patient scheduled to undergo surgery, the next day for removal.Patient underwent exploratory laparotomy and removal of retained drains under general anesthesia, no complications and patient discharged home.Per surgeon, drain was not caught in suture line and had not been damaged/melted by cautery.Stated, saw no marks or issues with drain when surgically removed them.Stated no known reason for the drain to snap.The portion that broke off in the clinic were not saved so only the portion in the patient that were surgically removed available to send to manufacturer." on (b)(4) 2017 we received two pieces of jp-2214 drains, only the white flat portions of them, broken off their shafts in the drain-shaft connection point.Investigation: the batch p1504640 was supplied to the customer in quantity of (b)(4) pieces on 04/07/2015.No non-conformities reported.No additional complaints received for similar failure.Batch history review of the batch p1504640 was performed.No non-conformities reported.The drains of this batch were sample tested for tensile strength (pulled until broke) in the connection area, exactly where the complained samples broke.The test results were ok: min.Result is 84.1n while the minimum requirement is 50 n.We inspected the retain sample from the batch p1504640.During the visual inspection, no cuts scratches or other damages detected.The sample was tested for tensile strength in the connection area with ok result: min.Result is 79.8 n while the minimum requirement is 50 n.(b)(4) samples from the current batch were tested for tensile strength in the connection area with ok result: min.Result is 77.6 n while the minimum requirement is 50 n.Conclusion: during internal investigation, we found no failures in our parts or processes.Silicone drains are known for their property to snap easily in area which was previously slightly damaged/cut/nicked.Probably, the drains were damaged in use and later snapped when pulled for removal.The complaint will be closed as not justified; no action is required in this case.

Event Description

(b)(6) year-old female had first post-op clinic visit.During attempt to remove 2 jp drains, they snapped off and potion remained in patient.Patient scheduled to undergo surgery the next day for removal.Patient underwent exploratory laparotomy and removal of retained drains under general anesthesia, no complications and patient discharged home.Per surgeon, drain was not caught in suture line and had not been damaged/ melted by cautery.Stated, saw no marks or issues with drain when surgically removed them.Stated no known reason for the drain to snap.The portion that broke off in the clinic was not saved, so only the portion in the patient that were surgically removed available to send to manufacturer.

• Brand Name: JACKSON-PRATT CHANNEL DRAIN
• Type of Device: FLAT FLUTED DRAIN, 10 MM
• Manufacturer (Section D): DEGANIA SILICONE LTD; degania bet; degania bet, jordan valley 15130 ; IS 15130
• Manufacturer (Section G): DEGANIA SILICONE LTD; degania bet; degania bet, jordan valley 15155 ; IS 15155
• Manufacturer Contact: katia kayam ; degania bet; degania bet, jordan valley 15155 ; IS 15155 ; 0046755107
• MDR Report Key: 6427123
• MDR Text Key: 70913309
• Report Number: 8030107-2017-00001
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/07/2016

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 Expiration Date: 02/01/2020
• Device Model Number: 10 MM
• Device Catalogue Number: JP-2214
• Device Lot Number: P1504640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR