MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X18IN 8-0 D/A BV130-5 EP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	EPM8738
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiovascular procedure on an unknown date and suture was used.The suture broke during use.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Component code: (b)(4) device not returned.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 information was requested, and the following was obtained: what tissue was being sutured when the event occurred? no further information is available.Lot number? lot number is rgbbjd.Event and procedure date? no further information is available.Event related to mw # 2210968-2022-02811, mw # 2210968-2022-02812, mw # 2210968-2022-02815.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/17/2022.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information: d9, h4, h6 additional h6 component code: g07002 reported condition not confirmed additional h3 investigation summary: six packets and empty opened overwrap of product code epm8738 were returned to ethicon for analysis.In order to evaluate the conditions of the returned samples, the six packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strands to detect any issue related to damaged or breakage suture and no defects were observed during the evaluation.A functional test was performed and the tensile strength force was above the minimum requirement.The event described could not be confirmed as the device performed without any defect noted.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, each batch is randomly inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PRLNE BLU 2X18IN 8-0 D/A BV130-5 EP
• 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: 14164015
• Report Number: 2210968-2022-02813
• Device Sequence Number: 2846095
• Product Code: GAW
• UDI-Device Identifier: 10705031218925
• UDI-Public: 10705031218925
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2022

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: 05/31/2026
• Device Model Number: EPM8738
• Device Catalogue Number: EPM8738
• Device Lot Number: RGBBJD
• 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: 03/28/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown