MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J464G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Were x-rays taken to locate the needle? was there any patient consequence or injury? what is the condition of the patient?.
Event or Problem Description
It was reported that the patient underwent a repair of lip laceration after a dog bite on (b)(6) 2019 and suture was used.While suturing mussel tissue the suture was used and as it was passed through tissue the needle popped off of the suture and embedded in the patients lip.The patient was sent to a plastic surgeon to remove the needle and address the patient lip.Additional information will be requested.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: how much of the needle was retained in the patient lip? whole.What tissue is the needle piece retained in? upper lip has an additional procedure been used to remove the needle piece? pt.Seen by plastic surgery.What was the date of the second procedure?unknown.Do you have the contact information for the plastic surgeon regarding needle for evaluation? no.What is the surgeons opinion as to the etiology of or contributing factors to this event? unknown.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 03/12/2020.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device mjz845 batch number, and no non-conformances were identified.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? how much of the needle was retained in the patient lip? what tissue is the needle piece retained in? has an additional procedure been used to remove the needle piece? what was the date of the second procedure? do you have the contact information for the plastic surgeon regarding needle for evaluation? what is the surgeons opinion as to the etiology of or contributing factors to this event? were x-rays taken to locate the needle? was there any patient consequence or injury? what is the condition of the patient?.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/2/2020.Additional information was requested and the following was obtained: were x-rays taken to locate the needle? yes.Was there any patient consequence or injury? unknown.What is the condition of the patient? unknown.

• Brand Name: VCL CT BRD VIO 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9808650
• Report Number: 2210968-2020-01855
• Device Sequence Number: 778638
• Product Code: GAM
• UDI-Device Identifier: 10705031040151
• UDI-Public: 10705031040151
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: J464G
• Device Catalogue Number: J464G
• Device Lot Number: MJZ845
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020; 03/13/2020; 04/09/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/12/2020; 04/02/2020; 04/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention