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
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebv0814 showed no other similar product complaint(s) from this lot number.Device not returned at this time.
Event or Problem Description
It was reported that the device was found to be kinked inside the package.Device was not used on patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a kinked catheter was confirmed and the cause appeared to be manufacturing related.The product returned for evaluation was an 8fr powerhickman catheter.The cuff and catheter appeared to have been unused.Gross visual evaluation of the catheter confirmed that the catheter was misshaped between the 23cm-24cm depth markings.The catheter tubing was bent at two locations and elliptical in cross-section with no evidence of a sharp-angled kink.The type of abnormality observed on the catheter would not have been likely to have occur during use and could have occurred if the catheter had migrated outside the intended tray slot during sealing or sterilization of the device.The sample was forwarded to the manufacturing facility for further review.A lot history review (lhr) of rebv0814 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the device was found to be kinked inside the package.Device was not used on patient.

• 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: 7289642
• Report Number: 3006260740-2018-00254
• Device Sequence Number: 1261466
• Product Code: LJS
• UDI-Device Identifier: 00801741036675
• UDI-Public: (01)00801741036675
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: REBV0814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1