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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM TUBING SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 X-STREAM TUBING SETS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Catalog Number 5552001
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/24/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
As reported, the x-stream tubing set is being returned for evaluation, however at this time, has not been received.Additional information has been requested.Based on the information provided and not having the sample returned for evaluation, no conclusion can be made.If/when sample is returned and evaluated, a supplemental mdr will be submitted.
 
Event or Problem Description
As reported, during an unspecified procedure on (b)(6) 2020, the laparoscopic irrigation x-stream tubing set w/ nd smokevac trumpet valve was leaking from the pump connector when connected to a normal saline (ns) bag.There was no reported patient injury.
 
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Brand Name
X-STREAM TUBING SETS
Common Device Name
LAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key11122827
Report Number1213643-2020-20093
Device Sequence Number11687684
Product Code GCJ
UDI-Device Identifier00801741010088
UDI-Public(01)00801741010088
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K003790
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,other,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/21/2020
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 Catalogue Number5552001
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/17/2020
Initial Report FDA Received Date01/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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