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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) -1313046 FILIFORM STRAIGHT TIP

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C.R. BARD, INC. (GFO) -1313046 FILIFORM STRAIGHT TIP Back to Search Results
Catalog Number 023805
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that the tip broke between the bard label and the number printed on the device; "where they screw onto. " the complainant alleged that there was a "slit in the insulation. " the device was not used on a patient.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. Information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
Received 1 filiform only. Visual inspection noted that the proximal end of the filiform was cracked/broken. No pieces of the filiform appeared to be missing. The result of the investigation was confirmed for a break near the proximal end however the root cause is unknown. Upon inspection of the returned sample, the catheter had a circumferential break at the proximal end, approximately 1 cm from the end. The break was brittle and propagated completely through the polyurethane to the woven core. The exact root cause of the break is undetermined. It is unknown if procedural or handling issues contributed to this event. It is also unknown how many times the catheter may have been resterilized and the resterilization process used. The break likely occurred during assembly with a mating catheter. The break likely occurred as a result of embrittlement due to aging. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "resterilization instructions: cautions: do not sterilize by irradiation or autoclaving. Inspect the product for signs of deterioration or damage (cracking, blistering, separation of coating). Discard if deterioration or damage is observed. Thoroughly rinse under cold and hot running water. Dry with sterile cloth or swabs. Place in a disinfectant solution, following the instructions of the disinfectant manufacturer. Then rinse all parts well with sterile water and dry thoroughly inside and out; sterilizing by ethylene oxide may be employed. Device to be sterilized should first be placed in appropriate packaging materials capable of maintaining sterility. Although cycle conditions and times will vary, typical conditions for ethylene oxide sterilization are 500 mg/l ethylene oxide, 50%-70% relative humidity (rh), and 120° - 130°f, with exposure time dependent on type of vessel. Check with bard (b)(4 for any available data on other means of sterilization; to ensure effectiveness, sterilization processes should be properly validated and monitored with the proper biological controls. Sterilization operations should proceed according to sterilizer manufacturer instructions; the cleaning, sterilization, and inspection procedures described above are based upon the manufacturer¿s experience with the catheter utilizing the manufacturer¿s equipment and facilities. These procedures must, therefore, be validated for their effectiveness by the user with the user¿s facilities. In particular, the effectiveness of sterilization should be validated and monitored using suitable biological controls. " (b)(4. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
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Brand NameFILIFORM STRAIGHT TIP
Type of DeviceFILIFORM STRAIGHT TIP
Manufacturer (Section D)
C.R. BARD, INC. (GFO) -1313046
289 bay road
queensbury NY 12804
Manufacturer (Section G)
C.R. BARD, INC. (GFO) -1313046
289 bay road
queensbury NY 12804
Manufacturer Contact
janna parks
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key5441043
MDR Text Key38980721
Report Number1018233-2016-00159
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 05/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number023805
Device Lot NumberGFSJ2932
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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