MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F

Model Number	5833350
Medical Device Problem Codes	Fracture (1260); Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation, however video was provided for review.The investigation of the reported event is currently underway.Expiry date (03/2021).
Event or Problem Description
It was reported that during a catheter placement, the plastic connector of introducer needle was broken.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation; however, one video was provided for review.The video shows one introducer needle connected to a syringe.The clinician trying to aspirate liquid from the container through the introducer needle but was unsuccessful.Based on the video review, the investigation is confirmed for the identified suction problem and inconclusive for the reported fracture issue.A definitive root cause could not be determined based upon available information.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: b5,d4(expiry date: 03/2021),g4.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.
Event or Problem Description
It was reported that during a catheter placement, the plastic connector of introducer needle was broken.It was further reported that, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10500622
• Report Number: 3006260740-2020-03186
• Device Sequence Number: 3155387
• Product Code: MSD
• UDI-Device Identifier: 00801741013362
• UDI-Public: (01)00801741013362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: REDS4823
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 69