MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON 10-0 CS160-6 D*; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number U7000

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Do you have any photos of the patient eye? does the patient have any symptoms from the foreign body? how did the substance become deeply embedded? what is the surgeon¿s opinion as to the contributing factor to the patient event? does the surgeon plan to remove the foreign body from the patient eye? was any medical intervention performed due to foreign body in patient cornea? what are the patient age, gender, weight, medical history? what is the surgeon opinion as to the long-term consequence to the patient? what is the current condition of the patient?.

Event Description

It was reported that a patient underwent emergency right eye full-thickness corneal graft procedure (penetrating keratoplasty) on (b)(6) 2018 and suture was used.The donor corneal graft was secured to patients right eye with suture.During the suturing, a yellowish glue-like substance (less than 1mm in size) was dislodged from the end of the needle and became entrapped deeply into the cornea.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Device photo evaluation summary: there was no sample received for analysis.Only a picture of the sample was received for analysis.Upon visual inspection of the picture, a needle inserted at foam with an excessive epoxy at the attachment area was noted.Additional information was requested and the following was obtained: do you have any photos of the patient eye? [a.But see other attached photos] other packs of same lot product have been checked, and found similar glue-like substance was located at the end of the suture needle and photos have been taken for it.Does the patient have any symptoms from the foreign body? [no obvious symptoms observed so far] how did the substance become deeply embedded? [the user found the tear-drop like substance embedded in the needle to suture anchoring point under microscope after several stitchings, then they found the same situation in the other suture with same code] what is the surgeon¿s opinion as to the contributing factor to the patient event? does the surgeon plan to remove the foreign body from the patient eye? [no foreign body was found inside the patient] was any medical intervention performed due to foreign body in patient cornea? [yes] what are the patient age, gender, weight, medical history? [na] what is the surgeon opinion as to the long-term consequence to the patient? [no comment at this moment, it take times to observe] what is the current condition of the patient? [no special comment ].

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.An unused opened sample (a needle-suture combination on the foam park) and two unopened samples of product code (b)(4), lot jce945 were returned for analysis.This product code is double armed.During the visual inspection of the opened sample, the swage and attachment area of needles were as expected, but, excess of epoxy was noted between the end barrel needle and the suture.The suture was examined along of strand and no defects were noted.No marks on the needles were observed.In the visual inspection of two unopened samples, no defects were found on the package.The samples were opened, and the swage and attachment area of needles were as expected, however excess of epoxy was noted between the end barrel needle and the suture.The suture was dispensed without problems and examined along of the strand and no defects or damaged were noted.Per the condition of the representative samples, the assignable cause is excessive epoxy additional information was requested and the following was obtained: additional information was received that no foreign body was found inside the patient and medical intervention was performed due to foreign body in patient cornea.What medical intervention was performed? results? [if the medical intervention refers to medicine intervention like additional drugs was given, the reply is "no".The surgeon only used microscope to check if there was any foreign body left in patient eye.].

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.Additional information was received that indicated this event now meets reporting criteria as malfunction.Device code: (b)(4) - excessive epoxy additional information was requested and the following was obtained: additional information was received that no foreign body was found inside the patient and medical intervention was performed due to foreign body in patient cornea.What medical intervention was performed? results? [if the medical intervention refers to medicine intervention like additional drugs was given, the reply is "no".The surgeon only used microscope to check if there was any foreign body left in patient eye.].

• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151
• MDR Report Key: 7644002
• MDR Text Key: 112547684
• Report Number: 2210968-2018-73905
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: U7000
• Device Lot Number: JCE945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention