MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 6-0 D/A BV-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8806H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Were x-rays performed to localize the needle? no further information is available.Was the needle removed from the patient? no further information is available.Procedure name and date? no further information is available.Event date? no further information is available.Device return status? the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided." note: events reported on mw# 2210968-2022-04915, mw# 2210968-2022-04916, mw# 2210968-2022-04917.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent an unknown surgery on an unknown date and suture was used.The connection part between the suture and the needle was easily detached.It was not a control release needle.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/28/2022.H6 component code: g07002 device problem not found.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Investigation summary: twenty-one packets of product code 8806h were returned for analysis.Visual inspection and functional test were conducted on the returned devices.During the visual inspection of sampling plan of thirteen samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no anomalies were observed.Functional test was performed using an instron and the pull force were above the minimum requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.Events reported on mw# 2210968-2022-04915, mw# 2210968-2022-04915, mw# 2210968-2022-04916, mw# 2210968-2022-04917.

• Brand Name: PRLNE BLU 18IN 6-0 D/A BV-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14843604
• Report Number: 2210968-2022-04914
• Device Sequence Number: 4743966
• Product Code: GAW
• UDI-Device Identifier: 10705031020696
• UDI-Public: 10705031020696
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2022

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 Expiration Date: 06/30/2026
• Device Model Number: 8806H
• Device Catalogue Number: 8806H
• Device Lot Number: RHBEDR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown