MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN CV CATHETER, PLOYURETHANE DUAL-LUMEN, 9.5F; CHRONIC CATHETERS

Model Number	0802915
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 0802915 chronic catheters allegedly experienced difficult or delayed separation.This report was received from one source.One patient was involved with no reported patient injury.Age, gender and weight were not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned for evaluation.Therefore, the investigation is confirmed for material separation, separation failure and inconclusive for difficult or delayed separation.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.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
This report summarizes one malfunction.A review of the reported information indicates that model 0802915 chronic catheters allegedly experienced difficult or delayed separation, material separation and separation failure.This report was received from one source.One patient was involved with no reported patient injury.Age, gender and weight were not provided.

• Brand Name: POWERHICKMAN CV CATHETER, PLOYURETHANE DUAL-LUMEN, 9.5F
• Common Device Name: CHRONIC CATHETERS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10738095
• Report Number: 3006260740-2020-03489
• Device Sequence Number: 11044583
• Product Code: LJS
• UDI-Device Identifier: 00801741036651
• UDI-Public: (01)00801741036651
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: No Information
• Device Model Number: 0802915
• Device Catalogue Number: 0802915
• Device Lot Number: REEQ2617
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1