MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT CATHETER; DIALYSIS CATHETER

Model Number	5733270
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/07/2021
Type of Reportable Event	Serious Injury
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, photos were provided for review.The investigation of the reported event is currently underway.Expiry date: 08/2021.
Event or Problem Description
It was reported that during dialysis catheter placement procedure, the plastic sleeve of the introducer allegedly torn off.It was further reported that the stucked broken part was allegedly removed via a second incision.The patient current status was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.A device history record review was performed and the lot met all release criteria.Investigation summary: the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is confirmed for the reported fracture, deformation and material separation issues as a complete fracture was noted on the plastic sleeve of the tunneler.Further kinks were noted on the fractured tunneler sleeve.The 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: d4 (expiry date: 08/2021), g3, h6 (method).H11: b5, h6 (device, result, conclusion).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 dialysis catheter placement procedure, the plastic sleeve of the introducer allegedly separated and remained in the patient.It was further reported that medical intervention was performed to remove the material from the patient.The patient's current status was unknown.

• Brand Name: HEMOSPLIT CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11769311
• Report Number: 3006260740-2021-01659
• Device Sequence Number: 3998283
• Product Code: MSD
• UDI-Device Identifier: 00801741013010
• UDI-Public: (01)00801741013010
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030020
• 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): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5733270
• Device Catalogue Number: 5733270
• Device Lot Number: REDX5029
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention