MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM); CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	3275135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, at this time, to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.[(b)(4)].Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that the picc was placed without difficulty, a dressing was applied and the catheter was flushed.However, while the patient was still on the table, the dressing was noticed to be filling with diluted bloody drainage.Dressing was removed and the picc was found to be leaking at the "y" hub.The picc was immediately exchanged without difficulty.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 5fr d/l powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed at the interface between the red-luered extension tubign and the molded joint.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.Sharply formed fracture edges.Planar shape to the fracture surface.Blood residue was seen on the sample which showed that the product had undergone at least some use.The short time frame between the insertion date and the date of discovery suggests this damage likely occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.(b)(4).
Event or Problem Description
It was reported that the picc was placed without difficulty, a dressing was applied and the catheter was flushed.However, while the patient was still on the table, the dressing was noticed to be filling with diluted bloody drainage.Dressing was removed and the picc was found to be leaking at the "y" hub.The picc was immediately exchanged without difficulty.No patient injury was reported.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY (135 CM)
• 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: 7770698
• Report Number: 3006260740-2018-02029
• Device Sequence Number: 11189004
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018
• Report Date (Section F): 07/19/2018

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: 3275135
• Device Catalogue Number: 3275135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1