MAUDE Adverse Event Report: ETHICON INC. PROLENE BLUE 1.5M 90CM W/2 NDL; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number W8329

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Additional information was requested, and the following was obtained: "what tissue was being approximated/ sutured?" unknown."was the needle found bent in the package?" no."did the needle bend during dispensing/ removal from package?" no."where was the needle grasped (swage, middle, body)?" unknown."where did the needle bend (swage, body, middle, tip)?" unknown."did the needle make contact with any hard surface?" no."in (b)(4), it is reported quantity of product involved is 45.Please clarify, is the 45 supposed to go into the quantity of product returned instead?" 45 ea will be returned."did the event occur during one or multiple patient procedures?" multiple."what is the total number of procedures?" unknown."have any of these events been previously reported to ethicon?" if so, provide the respective reference number(s).No."what is the procedure name?" cvs."what is the procedure date?" (b)(6) 2022."was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)?" if so, please specify.No.If medication was required, please clarify if it was prescribed by a physician.N/a."what is the most current patient status?" patient is fine."can you identify the product code and lot number of the product that was used?" w8329/ rcbbzj.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 Description

It was reported that a patient underwent a cardiovascular procedure on (b)(6) 2022 and suture was used.During the procedure, the suture was easily broken, and the needle was easily deformed.There were no patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint(b)(4).Date sent to the fda: 07/28/2022 this report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 evaluation: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that three sealed boxes with twelve packets ea.And nine packets of product were returned for analysis.Upon initial inspection, of the sample, no external damage was observed on the packets.A visual inspection was performed on samples, and no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected and no needle bending was observed.The suture was dispensed without problems and examined along the strand to detect any issue related to damaged or suture breakage and no defects were observed during evaluation.Functional test was performed, and the tensile strength result was above the minimum requirements.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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PROLENE BLUE 1.5M 90CM W/2 NDL
• Type of Device: 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14608086
• MDR Text Key: 301998084
• Report Number: 2210968-2022-04337
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K133356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: W8329
• Device Lot Number: RCBBZJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1