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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. BARD CHANNEL DRAIN; SURGICAL DRAIN
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C. R. BARD, INC. BARD CHANNEL DRAIN; SURGICAL DRAIN Back to Search Results
Catalog Number LIKE 072187
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Unspecified Infection (1930); Impaired Healing (2378)
Event Date 05/07/2019
Event Type  malfunction  
Event Description
Got to operating room on (b)(6) 2019 for left chest wound infection and vacuum assisted closure dressing change; while in pacu the j-p drain was pulled out.Pt stated she went to the bathroom and accidentally sat on it causing the drain to be pulled out.Surgeon notified and he removed the remainder of the drain and redressed the wound.The drain tubing came apart from just underneath her dressing with the bulb end attached.The jp bulb was secured to the ace wrap with a safety pin.Pt admitted (b)(6) 2019 with post-op infection of left breast from breast augmentation and lift on (b)(6) 2018 in "(b)(6)." multiple surgical procedures since then for non-healing wound.
 
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Brand Name
BARD CHANNEL DRAIN
Type of Device
SURGICAL DRAIN
Manufacturer (Section D)
C. R. BARD, INC.
covington GA 30014
MDR Report Key8662801
MDR Text Key147186466
Report Number8662801
Device Sequence Number1
Product Code GCY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2023
Device Catalogue NumberLIKE 072187
Device Lot NumberLIKE NGCZ1063
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/28/2019
Distributor Facility Aware Date05/07/2019
Event Location Hospital
Date Report to Manufacturer05/28/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
Patient Weight51
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