MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERHICKMAN 8F SINGLE-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0805815
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the device packaging has an alleged cut.No patient involvement.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria, this is the first complaint reported for this lot number and issue to date.Investigation summary: one sealed power hickman 8f 47cm catheter kit was returned.A visual inspection was performed.The outer cover showed a clear vertical gash through the outer cover and medially located on the front package.No corresponding damage was noted to the inner components or reverse side of the packaging.Therefore, the investigation is confirmed a cut to the packaging.There is no indication that the sterile barrier breach is related to a design failure, as the power hickman packaging configuration had a no test rationale based on the ship testing performed on the hemosplit catheter kit.The ship test qualification confirmed that the packaging configuration is sufficient to maintain a sterile barrier after exposure to international safe transit association (istg) conditioning.The definitive root cause for the slit identified in the device packaging could not be determined based on the provided information.However, it is unlikely that the slit in the packaging is manufacturing related.It is unknown if device handling and/or storage conditions at the user facility contributed to the reported event.Labeling review:a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Expiry 01/2020.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 the device packaging has an alleged cut.No patient involvement.

• Brand Name: POWERHICKMAN 8F SINGLE-LUMEN POLYURETHANE CATHETER WITH SURECUFF INGROWTH CUFF
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7711725
• Report Number: 3006260740-2018-01773
• Device Sequence Number: 19175012
• Product Code: LJS
• UDI-Device Identifier: 00801741036675
• UDI-Public: (01)00801741036675
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 0805815
• Device Catalogue Number: 0805815
• Device Lot Number: RECQ1482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1