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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN FILIFORM SPIRAL TIP 12.5IN (31.75CM) 2 FR., STERILE

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C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN FILIFORM SPIRAL TIP 12.5IN (31.75CM) 2 FR., STERILE Back to Search Results
Catalog Number 022102
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/23/2017
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. 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 medical services and support (1-800-227-3357) 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).
 
Event Description
It was reported that the packaging was found without a product of origin.
 
Manufacturer Narrative
Received 3 photo samples from the product user. The reported event was confirmed; however, the root cause is unknown. The package in the photo had been opened already. Therefore, it cannot be determined if the product missing from the inside of the package was due to packaging or manufacturing related issues. It was not stated by the complainant whether the pouch was sealed when accessed for use. 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 medical services and support (b)(6) 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).
 
Event Description
It was reported that the packaging was found without a product of origin.
 
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. The device was not returned.
 
Event Description
It was reported that the packaging was found without a product of origin.
 
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. The device was not returned.
 
Event Description
It was reported that the packaging was found without a product of origin.
 
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Brand NameBARD WOVEN FILIFORM SPIRAL TIP 12.5IN (31.75CM) 2 FR., STERILE
Type of DeviceFILIFORM
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6489837
MDR Text Key163873136
Report Number1018233-2017-01784
Device Sequence Number1
Product Code FBW
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number022102
Device Lot NumberGFAY1130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2017
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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