MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. BASX BLADELESS TROCAR 5MM

Catalog Number	TB5LT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
Packaging breakage.Found the sterile packaging was damaged.
Additional Manufacturer Narrative
(b)(4).Batch # r93f37.Device analysis: the analysis results found that a tb5lt device was returned inside its package partially opened.Upon visual inspection, the seal area was inspected and evidence of being properly sealed was found in the package.Due to the damages found on the packaging, a possible cause for these conditions is due to improper handling during transit or storage.All ees product is 100% inspected prior to release.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Additional Manufacturer Narrative
(b)(4).Upon further review of the event and additional information received, this does not meet the fda defined criteria for a reportable event as there was no issue with the integrity of the packaging.

• Brand Name: BASX BLADELESS TROCAR 5MM
• Common Device Name: BASX BLADELESS TROCAR
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7873985
• Report Number: 3005075853-2018-12691
• Device Sequence Number: 19455185
• Product Code: GCJ
• UDI-Device Identifier: 20705036003028
• UDI-Public: 20705036003028
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: TB5LT
• Device Lot Number: R40L28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 09/12/2018; 10/08/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/28/2018; 10/15/2018
• Patient Sequence Number: 1