MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK CATHETER 19 CM, 19 CM STRAIGHT DL W AIRGUARD; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5913190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photos were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.(expiration date: 07/2020).
Event or Problem Description
It was reported that during the placement of the dialysis catheter, the dilator allegedly broke when attempting to take the inner stylet out.Reportedly, the device was removed and replaced.There was no reported patient injury.
Event or Problem Description
It was reported that during the placement of the dialysis catheter, the dilator allegedly broke when attempting to take the inner stylet out.Reportedly, the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturer review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for damaged/defective dilator tip, as the photo review could not confirm a deficiency/ functional issue.The definitive root cause could not be determined based upon available information.As only an electronic photograph was returned, the alleged device could not be examined further.It is unknown if procedural issues contributed to the reported event.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.

• Brand Name: EQUISTREAM XK CATHETER 19 CM, 19 CM STRAIGHT DL W AIRGUARD
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8675756
• Report Number: 3006260740-2019-01568
• Device Sequence Number: 13998903
• Product Code: MSD
• UDI-Device Identifier: 00801741013836
• UDI-Public: (01)00801741013836
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 5913190
• Device Catalogue Number: 5913190
• Device Lot Number: RECX3045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 70