MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F

Model Number	5743730
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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: 12/2020).
Event or Problem Description
It was reported that the connector for introducer needle was allegedly damaged and was leaking air.There was no reported patient injury.
Event or Problem Description
It was reported that the connector for introducer needle was allegedly damaged and was leaking air.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is confirmed for the reported fractured introducer needle hub as cracks on the needle hub is evident in the provided photo.However, the investigation is inconclusive for the reported leak issue as the device was not returned for evaluation and the provided photo is not sufficient to confirm this issue.A definitive root cause could not be determined.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: 12/2020).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.H3 other text : device not returned.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F
• 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: 11122171
• Report Number: 3006260740-2020-21176
• Device Sequence Number: 897140
• Product Code: MSD
• UDI-Device Identifier: 00801741013287
• UDI-Public: (01)00801741013287
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/05/2021

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: 5743730
• Device Catalogue Number: 5743730
• Device Lot Number: REDP2831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2020
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 05/17/2021
• 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: Other
• Patient Age: 78 YR
• Patient Weight: 71