MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK 45CM M1 5/0 P-6; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1601T

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.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.Was only the outer box package labelling on the 2 boxes incorrect with conflicting information but with correct product primary packets (as per required order) inside the boxes? were the boxes opened to see if there was correct suture product w1601t (9mm 3/8 circle reverse cutting needle on a 5/0 ethilon) as per order requirements, inside the boxes? what was the suture product (suture name) that arrived in new boxes with 8mm ¼ circle reverse cutting needle? what was the product code/lot of suture product received with package description of 8mm ¼ circle reverse cutting needle? there is no photo attached to file as stated in event description, do you have any photos available for initial evaluation?.

Event Description

It was reported by a facility that when the box of suture arrived on (b)(6) 2018 at the hospital, the packaging stated that it contained a needle that was different than expected based on what the facility ordered from the description from a catalog.The facility did not open the box to see what needle was inside.There were no adverse patient consequences reported.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.A sealed box was returned for analysis.During the visual inspection of the box, no defects were observed.The information of product code, lot number and graphic on the label box printed was compared with our system and are correct.No discrepancies or issues were noted.Due to the sample condition, no defects were found at the information on the box as is correct according to our system.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.It was reported that the information on the supply chain website verses the information on the box of suture was loaded incorrectly at the supply chain and contained the incorrect description on their website.The customer reported that this should never have been recorded as a product complaint.In addition, the evaluation revealed that a sealed box was returned for analysis.During the visual inspection of the box, no defects were observed.The information of product code, lot number and graphic on the label box printed was compared with our system and are correct.No discrepancies or issues were noted.Based on this information, this medwatch report is not malfunction reportable.

• Brand Name: ETHILON BLK 45CM M1 5/0 P-6
• 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.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7655041
• MDR Text Key: 113004400
• Report Number: 2210968-2018-73980
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: W1601T
• Device Lot Number: LPZ791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1