MAUDE Adverse Event Report: ETHICON INC. PDS II (POLYDIOXANONE) SUTURE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number Z316H

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

Patient Problems Unspecified Infection (1930); Surgical procedure, additional (2564)

Event Date 05/01/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent a caesarean section on (b)(6) 2015 and suture was used.During the procedure, the needle was buried into the fat under the skin.While trying to pick it out from the swage side grasping the suture, the suture came away.The needle remained in the fat under the skin.Additional surgery was performed and the needle was retrieved.Following the procedure, the patient developed an infection.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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

(b)(4).Conclusion: representative samples were returned for evaluation.Visual and functional inspections were performed and the samples met the requirements.

• Brand Name: PDS II (POLYDIOXANONE) SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4812715
• MDR Text Key: 5894754
• Report Number: 2210968-2015-06597
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: Z316H
• Device Lot Number: GGM797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2013
• 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