MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. INSUFFLATION NEEDLE

Catalog Number PN150

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 5/13/2016.Pt info; relevant tests/lab data, other relevant history; concomitant medical products: information was not provided by the initial contact.Model and lot #; evaluation info: information is unavailable.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.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that prior to an unknown procedure, "num renal unit stated that needle does not retract as stated in ifu.Product used to insert renal dialysis catheters." it is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4) date sent: 6/28/2016 h6: result code = 141, failure to cycle the instrument product code pn150 was returned intact, opened and with tyvek for analysis.Analysis of the device found the stylet does not return when pulled back.Grinding felt when pulling stylet back and forth: unable to tell if resistance is in the handle or needle portion of device.Also returned; a sales unit box from same packaging lot which contained eleven unopened devices product code pn150.One of the eleven devices exhibited an issue with stylet not returning or deploying.The other ten devices functioned as normal.Based upon the visual and functional examination, it was concluded that the customer¿s complaint was confirmed.No conclusion could be reach as to what may have caused the issue.The batch history records were reviewed with no anomalies noted.

Manufacturer Narrative

(b)(6)/(b)(4).This report is being submitted per the request of fda to correct sequential numbering for the mdr follow up report originally submitted.This is follow up report #1.G6: follow-up report number.

Manufacturer Narrative

(b)(4).Date sent: 1/24/2024.This report is being submitted per the request of fda to correct sequential numbering for the mdr follow up report originally submitted.This is follow up report #2.G6: follow-up report number.

• Brand Name: INSUFFLATION NEEDLE
• Type of Device: INSUFFLATION NEEDLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5653421
• MDR Text Key: 45211928
• Report Number: 3005075853-2016-02711
• Device Sequence Number: 1
• Product Code: FDP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K910875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2020
• Device Catalogue Number: PN150
• Device Lot Number: M4HX0T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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