MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ENDOPATH; NEEDLE

Catalog Number DNYJ36692A

Device Problems Inflation Problem (1310); Occlusion Within Device (1423)

Patient Problem No Information (3190)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

After insertion of veres needle into patient's abdomen, carbon dioxide gas was attached and inflation of peritoneal space attempted.No inflation noted and insufflator indicated occlusion.Veres needle removed and new one opened.Insufflation reattempted and was successful.Probable defective insufflation needle.
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manufacturer response for veres needle, 120mm pneumoneedle (per site reporter).
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infomed medline via email - they provide packs with the needles wrapped inside.Please note that medline gets the product from ethicon endo but we report to medline first.

• Brand Name: ENDOPATH
• Type of Device: NEEDLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 3608150
• MDR Text Key: 16449876
• Report Number: 3608150
• Device Sequence Number: 1
• Product Code: BSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2014

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: Physician
• Device Catalogue Number: DNYJ36692A
• Device Lot Number: 13JB3403
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 95