MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 35CM, STAND; DIALYSIS CATHETER

Model Number	5833350
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.A photo was provided for review.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 03/2020).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 dialysis catheter package, the package was allegedly torn.There was no patient contact.
Event or Problem Description
It was reported that upon opening the dialysis catheter package, the package was allegedly torn.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.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, two electronic photos were provided for review.The photos were reviewed by engineering, the packaging engineering department, and the hemostar packaging ship test report was reviewed by post market quality.The investigation is confirmed for tear in packaging, as a tear was identified in the outer pouch.The tear appeared to go through the entire thickness of the outer pouch packaging.The definitive root cause for the tear identified in the device packaging could not be determined based on the provided information.However, it is unlikely that the tear in the packaging is manufacturing related.It is unknown if device handling and/or storage conditions at the user facility contributed to the reported event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g4.H11: h6 (results 1, conclusion 1).H11:section a through f - 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.

• Brand Name: HGSTAR, 14.5 FR, ST, 35CM, STAND
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9671250
• Report Number: 3006260740-2020-00391
• Device Sequence Number: 16238037
• Product Code: MSD
• UDI-Device Identifier: 00801741013362
• UDI-Public: (01)00801741013362
• Combination Product (Y/N): N
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 5833350
• Device Catalogue Number: 5833350
• Device Lot Number: RECW1157
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1