BARD MALECOT DRAIN 086016

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-11-22 for BARD MALECOT DRAIN 086016 manufactured by C.r. Bard, Inc..

Event Text Entries

[18826054] It was reported that a pt with left lower lobe pneumonia with a history of emphysema had three malecot catheters inserted on 07/22/05 for optimal drainage. The pt had a partial rib resection as well. The pt was discharged home and on 09/07/05 and six weeks and four days later, the pt returned to the clinic to have the drains removed. The tip of the last catheter to be removed remained inside the pt and was confirmed by cat scan. The pt was taken to the operating room the next day and the retained foreign object was surgically removed via an incision to retrieve the tip. The surgeon states that he applied normal traction when pulling catheters out. Traction was equal for all three. Also, upon review of the tip, it was such a clean break at the bendable portion of the malecot tip that it looked cut, but was not. There are four spokes that create a flange appearance. Three of the four spokes gave way right at the bent portion. The fourth spoke held. Additional info has been requested but has not been rec'd. It is unclear how the fourth spoke could have held yet the tip of the catheter remained inside the pt.
Patient Sequence No: 1, Text Type: D, B5

[18909650] No sample or lot number info was provided for eval. According to the reporter, the sample is missing and cannot be located. A review of the manufacturing process showed there are in-process controls designed to minimize defects from getting into the field that include a 100% visual inspection. In addition, defect awareness meetings are held where operators are informed of reported defects and are made aware of how their specific operation can affect product.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1018233-2006-00199
• MDR Report Key: 790772
• Report Source: 00
• Date Received: 2006-11-22
• Date of Report: 2006-11-22
• Date of Event: 2005-09-07
• Date Reported to FDA: 2006-08-14
• Date Mfgr Received: 2006-10-23
• Date Added to Maude: 2006-12-07
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: VIVIAN STEPHENS, MANAGER
• Manufacturer Street: 8195 INDUSTRIAL BLVD
• Manufacturer City: CONVINGTON GA 30014
• Manufacturer Country: US
• Manufacturer Postal: 30014
• Manufacturer Phone: 7707846902
• Manufacturer G1: BARD MEDICAL
• Manufacturer Street: 428 POWER HOUSE RD
• Manufacturer City: MONCKS CORNER SC 29461
• Manufacturer Country: US
• Manufacturer Postal Code: 29461
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARD MALECOT DRAIN
• Generic Name: MALECOT DRAIN
• Product Code: FEW
• Date Received: 2006-11-22
• Model Number: NA
• Catalog Number: 086016
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 734161
• Manufacturer: C.R. BARD, INC.
• Manufacturer Address: 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US
• Baseline Brand Name: BARDEX MALECOT LATEX DRAIN
• Baseline Generic Name: MALECOT DRAIN
• Baseline Model No: NA
• Baseline Catalog No: 086016
• Baseline ID: NA
• Baseline Device Family: LATEX MALECOT DRAIN
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K910197
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-11-22