MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 19CM, ST,SPLIT TIP, STANDARD KIT; DIALYSIS CATHETER

Model Number	5903190
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical images have been made available to the manufacturer.Medical records were not provided or reviewed.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 or Problem Description
It was reported that a dialysis catheter was identified as allegedly widened and flattened near the hub with discoloration.It was further reported that the device was not functioning and was removed and a new catheter was inserted.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the dhr review is not available because the corporate lot number is unknown.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, possible complications and contraindications showed that the product labeling is adequate.Investigation summary: two photos were evaluated and they are consistent with the evaluation.The discoloration noted on the catheter seems to be a byproduct of residue stains on the sample and the bending and flattening of the material.The sample returned for evaluation was one 14.5 fr 19 cm equistream catheter.Visual and functional evaluations were performed of the physical sample.Both lumens were patent to infusion and aspiration.A bulge and bend were noted along the catheter shaft, approximated 25mm distal to the bifurcation.Therefore, this investigation is confirmed for material deformation - catheter kink.The observed features of the catheter damage appear to be a result from kinking and over-pressurization of the device.However, which one led to the other could not be determined and therefore the definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.
Event or Problem Description
It was reported that a dialysis catheter was identified as allegedly widened and flattened near the hub with discoloration.It was further reported that the device was not functioning and was removed and a new catheter was inserted.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the dhr review is not available because the corporate lot number is unknown.Investigation summary: the sample returned for evaluation was one 14.5 fr 19 cm catheter.Visual and functional evaluations were performed of the physical sample.Both lumens were patent to infusion and aspiration.A bulge and bend were noted along the catheter shaft, approximated 25mm distal to the bifurcation.Therefore, this investigation is confirmed.The observed features of the catheter damage appear to be a result from kinking and over-pressurization of the device.However, which one led to the other could not be determined and therefore the definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, possible complications and contraindications showed that the product labeling is adequate.The information provided by bd 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 bd.
Event or Problem Description
It was reported that a dialysis catheter was identified as allegedly widened and flattened near the hub with discoloration.It was further reported that the device was not functioning and was removed and a new catheter was inserted.There was no reported patient injury.

• Brand Name: OTW, 14.5 FR, 19CM, ST,SPLIT TIP, STANDARD KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7842343
• Report Number: 3006260740-2018-02341
• Device Sequence Number: 1940645
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2019

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: Health Professional
• Device Model Number: 5903190
• Device Catalogue Number: 5903190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 08/08/2018
• Supplement Date Received by Manufacturer: 02/11/2019; 05/10/2019
• Initial Report FDA Received Date: 09/04/2018
• Supplement Report FDA Received Date: 02/25/2019; 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1