MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-17 for FILIFORM STRAIGHT TIP 023805 manufactured by C.r. Bard, Inc. (gfo) -1313046.
[38980721]
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.
Patient Sequence No: 1, Text Type: N, H10
[38980722]
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.
Patient Sequence No: 1, Text Type: D, B5
[40159480]
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.
Patient Sequence No: 1, Text Type: N, H10
[41727556]
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.
Patient Sequence No: 1, Text Type: N, H10
[44792655]
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.
Patient Sequence No: 1, Text Type: N, H10
[45580290]
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.
Patient Sequence No: 1, Text Type: N, H10
[47813653]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1018233-2016-00159 |
| MDR Report Key | 5441043 |
| Date Received | 2016-02-17 |
| Date of Report | 2016-05-20 |
| Date Mfgr Received | 2016-05-20 |
| Device Manufacturer Date | 2008-12-05 |
| Date Added to Maude | 2016-02-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANNA PARKS |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) -1313046 |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FILIFORM STRAIGHT TIP |
| Generic Name | FILIFORM STRAIGHT TIP |
| Product Code | FBW |
| Date Received | 2016-02-17 |
| Returned To Mfg | 2016-02-16 |
| Catalog Number | 023805 |
| Lot Number | GFSJ2932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (GFO) -1313046 |
| Manufacturer Address | 289 BAY ROAD QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-17 |