MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CP-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z969H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an animal underwent an unknown procedure in (b)(6) 2022 and suture was used.During the procedure, the suture breaks when they go to tie off the suture.They are seeing bleeding with some of the suture breaks.There were no other patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: what is the lot number? could you please confirm device's availability? could you please confirm how many times did this issue occurred? did any patient suffer from any consequence due to this issue? could you please provide information about quantity of blood loss of the patient? was medical or surgical intervention performed due to the bleeding? if yes, please describe.Device return follow up.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.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: what is the lot number? could you please confirm device's availability? could you please confirm how many times did this issue occurred? did any patient suffer from any consequence due to this issue? could you please provide information about quantity of blood loss of the patient? was medical or surgical intervention performed due to the bleeding? if yes, please describe.Device return follow up.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.
Event or Problem Description
It was reported that an animal underwent an unknown procedure in (b)(6) 2022 and suture was used.During the procedure, the suture breaks when they go to tie off the suture.They are seeing bleeding with some of the suture breaks.There were no other patient consequences reported.Additional information was requested.

• Brand Name: PDSII VIO 27IN 2-0 S/A CP-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13602123
• Report Number: 2210968-2022-01316
• Device Sequence Number: 12205518
• Product Code: NEW
• UDI-Device Identifier: 10705031061941
• UDI-Public: 10705031061941
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2022

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
• Operator of Device: Health Professional
• Device Model Number: Z969H
• Device Catalogue Number: Z969H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown