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

Model Number	5903190
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
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.(expiry date: 09/2020).
Event or Problem Description
It was reported that the dialysis kit allegedly contained the incorrect dilator.The procedure was completed successfully.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: per the complaint history review (chr), this is the first and only complaint reported for this lot number.A dhr (device history record) review is not required.Investigation summary: two electronic photos were reviewed by (b)(6) (bdpi field assurance engineer).One photo shows the hubs of two 12 fr dualators.A part of the blue shaft of both dualators can be seen in the photos.Both dualators appear to be clean and no damage/defects can be observed in the photo.The second photo shows labeling for equistream¿ long-term hemodialysis catheter with preloaded stylet, 14.5 fr, straight, 19 cm.The product catalog number 5903190 is visible in the photo.However, the lot number is blurry in the photo.Based on the photo review, an incorrect/extra component cannot be confirmed.Although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for incorrect/extra component, as the rest of the equistream kit in sealed packaging was not visible in the photos provided.Although two 12 fr dualators were visible in the provided photos, the rest of the kit and packaging tray were not visible in the photos provided.The definitive root cause could not be determined based upon available information, as the condition of the alleged kit at time of receipt in sealed packaging is unknown.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.
Event or Problem Description
It was reported that the dialysis kit allegedly contained the incorrect dilator.The procedure was completed successfully.There was no reported patient injury.

• Brand Name: OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT
• 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: 8803037
• Report Number: 3006260740-2019-02013
• Device Sequence Number: 343048
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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: REDR0715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 82