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

Model Number	0802915
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
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, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2022).
Event or Problem Description
It was reported that during preparation of an catheter placement procedure, the catheter cuff allegedly dislocated at "0 cm" instead of "2 cm".It was further reported that catheter was not implanted because of defective cuff location.There was no patient contact.
Additional Manufacturer Narrative
The file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.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 device was not returned for evaluation.Although two electronic photo was provided for review.First photo shows power hickman catheter with tissue cuff starting at the zero(0) mark.Second photo shows the unit label of the product reflecting catalogue and batch number.The location of the tissue cuff in the provided photo was in sync with the drawing file.Therefore, the investigation is unconfirmed for the reported defective component.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.10: d4 (expiry date: 05/2022).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.
Event or Problem Description
It was reported that during preparation of an catheter placement procedure, the catheter allegedly found defective and cuff located at 0 cm instead of 2 cm.It was further reported that catheter was not implanted because of defective cuff location.There was no patient contact.

• Brand Name: POWERHICKMAN CV CATHETER, POLYURETHANE DUAL-LUMEN, 9.5F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11656051
• Report Number: 3006260740-2021-01292
• Device Sequence Number: 19717308
• Product Code: LJS
• UDI-Device Identifier: 00801741036651
• UDI-Public: (01)00801741036651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/03/2021

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: 0802915
• Device Catalogue Number: 0802915
• Device Lot Number: REEW2677
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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