MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 8555H

Device Problems Needle, separation (1415); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Bleeding (1738); Surgical procedure (2357)

Event Date 06/08/2015

Event Type  Injury  

Manufacturer Narrative

The portal vein was being sutured when the needle pulled off the suture.It was reported that the bleeding that lead to the second procedure was not related to the suture because, the place which had the second procedure was different from the place that the device was used.The current condition of the patient was reported as doing well.Conclusion: no conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Event Description

It was reported that the patient underwent a surgical procedure on (b)(6) 2015 and suture was used.During distention of the common bile duct, bleeding was found before closing the wound.Suture was used to stop the hemorrhage.When penetrating the suture into the tissue, the needle came away from the suture.The needle fell into the patient's body and was retrieved by using x-ray.Approximately midnight on (b)(6) 2015, the patient experienced bleeding and underwent another surgical procedure.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.(b)(4).

• Brand Name: PROLENE POLYPROPYLENE SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 0075 4
• Manufacturer Contact: mary szaro ; 9082183464
• MDR Report Key: 4887386
• MDR Text Key: 14221099
• Report Number: 2210968-2015-07767
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 8555H
• Device Lot Number: EAB303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention