MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM CATHETER - STRAIGHT, POLYURETHANE CATHETER; DIALYSIS CATHETER

Model Number	5913230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2019
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 return of the device is pending.The investigation is currently under way; (09/2020).
Event or Problem Description
It was reported that upon opening the package, the tip of the tunneler was identified broken.It was further reported that anther device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: based upon the severity level and lot quantity, a dhr review is required.Manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary: one equistream xk 23cm 16f catheter and tunneler was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the proximal tip of the tunneler was broken off and not received.The break was observed to be partially smooth, dull, and uneven.The portion of the break surface protruding was observed to be smooth and shiny.The definitive root cause for the reported damaged tunneler issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.However, vt-sca-19-4398 is currently opened to address the issue and identify appropriate actions.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.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 upon opening the package, the tip of the tunneler was identified broken.It was further reported that anther device was used to complete the procedure.There was no patient contact.

• Brand Name: EQUISTREAM CATHETER - STRAIGHT, POLYURETHANE CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8383265
• Report Number: 3006260740-2019-00438
• Device Sequence Number: 1633691
• Product Code: MSD
• UDI-Device Identifier: 00801741013843
• UDI-Public: (01)00801741013843
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: RECX3719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1