C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN FILIFORM SPIRAL TIP 12.5IN (31.75CM) 2 FR., STERILE
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Catalog Number 022102 |
Device Problem
Incomplete or Missing Packaging (2312)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the packaging was found without a product of origin.
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the packaging was found without a product of origin.
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Manufacturer Narrative
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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).
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Event Description
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It was reported that the packaging was found without a product of origin.
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Manufacturer Narrative
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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).
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Event Description
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It was reported that the packaging was found without a product of origin.
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Search Alerts/Recalls
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