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

Catalog Number	022102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the packaging was found without a product of origin.
Additional 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 or Problem Description
It was reported that the packaging was found without a product of origin.
Additional 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 or Problem Description
It was reported that the packaging was found without a product of origin.
Additional 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 or Problem Description
It was reported that the packaging was found without a product of origin.

• Brand Name: BARD WOVEN FILIFORM SPIRAL TIP 12.5IN (31.75CM) 2 FR., STERILE
• Common Device Name: FILIFORM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6489837
• Report Number: 1018233-2017-01784
• Device Sequence Number: 13705535
• Product Code: FBW
• UDI-Device Identifier: 00801741073144
• UDI-Public: (01)00801741073144(17)220128(10)GFAY1130
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/01/2017

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: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 022102
• Device Lot Number: GFAY1130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 10/25/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 05/08/2017; 06/24/2017; 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1