MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that one of the hubs on a triple lumen picc broke at the extension leg while in use on the patient.A new device was placed.
Event or Problem Description
It was reported that one of the hubs on a triple lumen picc broke at the extension leg while in use on the patient.A new device was placed.
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a separation of the hub from the extension leg tubing was confirmed and the damage appeared to be associated with use of the device.One 5fr triple-lumen (t/l) powerpicc solo was returned for investigation.The catheter exhibited evidence of use.A dry red colored residue was observed on the catheter.The t/l tubing and the power injectable extension leg tubing were each received in two segments.The printing on the extension leg was elongated and worn.The distal segment of the power injectable tubing extended 0.25¿ from the proximal end of the molded trifurcation.The proximal segment was 5.0¿ and a knot was observed in the tubing 1.0¿ from the proximal end of the extension leg.The length of the extension set tubing and the length of the printed working on the tubing was beyond the specification length, which confirms that the tubing was stretched.It appeared that the proximal end of the extension leg completely separated from the solo hub without breaking.The solo hub for the power injectable lumen was not returned for investigation.Due to the characteristics of the returned sample and plastic deformation of the extension set tubing, it appeared that the damage was a result of significant tensile stress during use.No damaged associated with the manufacturing process was observed on the returned sample.A lot history review (lhr) of reds0262 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC SOLO HF CATHETER 5F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70CM)
• 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: 9447682
• Report Number: 3006260740-2019-03801
• Device Sequence Number: 2230985
• Product Code: LJS
• UDI-Device Identifier: 00801741028380
• UDI-Public: (01)00801741028380
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: N/A
• Device Catalogue Number: 3395355Q
• Device Lot Number: REDS0262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR