MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DECATHLON DF 19 CM INT; DIALYSIS CATHETER

Model Number	DF19IT24K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 02/2021).
Event or Problem Description
It was reported that upon opening the dialysis catheter kit the arterial lumen of the catheter was allegedly found torn.It was further reported that another kit was used to perform the procedure.There was no patient involvement.
Event or Problem Description
It was reported that upon opening the dialysis catheter kit the arterial lumen of the catheter was allegedly found torn.It was further reported that another kit was used to perform the procedure.There was no patient involvement.
Additional Manufacturer Narrative
Manufacturing review:per the complaint history review (chr), this is the only complaint reported for this lot number to date.A device history record review is not required.Investigation summary: two electronic photos were reviewed.The photo labeled as 1460838 photo 1.Jpg shows a portion of a decathlon catheter shaft.Neither proximal ends nor distal end of the device can be seen in the photo.A distal portion of one of lumens appears to be missing, as the distal end of one of the lumens is sharply inclined, suggesting a full break in one of the lumens.The photo labeled as 1460838 photo 2.Jpg shows a zoomed out view of a part of the catheter shaft.The distal end of the other, apparently unbroken lumen with a portion of the stylet exiting from the lumen distal tip can be seen.The inclined distal end of the apparently broken lumen observed in the previous photo can be seen.Based on the photo review, a full break in one of the catheter shaft lumens can be confirmed.One 19cm decathlon df d/l catheter with stylet inserted in the arterial lumen and two electronic photos were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for a complete break in one of the catheter shaft lumens, as the distal end of the venous lumen was observed to be detached approximately 15.1 cm from the distal end of the bifurcation.The distal end of the venous lumen was inclined towards the proximal end of the device and the break surface was observed to be jagged.The returned sample appeared to be clean.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Expiry date 02/2021.

• Brand Name: DECATHLON DF 19 CM INT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9101146
• Report Number: 3006260740-2019-02800
• Device Sequence Number: 2623127
• Product Code: MSD
• UDI-Device Identifier: 00801741013935
• UDI-Public: (01)00801741013935
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2019

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: DF19IT24K
• Device Catalogue Number: DF19IT24K
• Device Lot Number: REDS0399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1