MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F; CHRONIC CATHETER

Model Number	0805915
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
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, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2022).
Event or Problem Description
It was reported that during preparation of an catheter placement procedure, the catheter allegedly kinked.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that during preparation of a catheter placement, the catheter was allegedly kinked.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 9.5 fr power hickman d/l catheter were returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported catheter kink issue as there was a s-shaped kink situated approximately 25.0cm distal to the y-body was also seen in the provided photo.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.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: POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11876674
• Report Number: 3006260740-2021-01998
• Device Sequence Number: 3661012
• Product Code: LJS
• UDI-Device Identifier: 00801741036699
• UDI-Public: (01)00801741036699
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2021

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: 0805915
• Device Catalogue Number: 0805915
• Device Lot Number: REEW0423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 09/02/2021
• 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