MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ULTRA VERESS INSUFFLATION NEEDLE - 120MM LENGTH

Catalog Number UV120

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 the material was with damaged packaging (packaging route), compromising the sterilization process.The event was identified immediately on receipt of the product in the hospital.It was not used in a patient.

Manufacturer Narrative

(b)(4).Batch # m49521.The analysis results found that uv120 device was returned inside its package.Upon visual inspection, it was observed that the tyvek from the packaging was damaged; it was noted to have hole in the tyvek at the tip area of the device, the hole was noted to be from the inside out.In addition, the tyvek was noted with wrinkles and evidence that it was stapled.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.All ees product is 100% inspected prior to release.The information you provided is compiled monitored and reviewed on a routine basis for any associated trends.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.

• Brand Name: ULTRA VERESS INSUFFLATION NEEDLE - 120MM LENGTH
• 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: 5604900
• MDR Text Key: 44206072
• Report Number: 3005075853-2016-02247
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2016

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 Expiration Date: 09/14/2020
• Device Catalogue Number: UV120
• Device Lot Number: M4J47U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/01/2016
• Initial Date FDA Received: 04/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1