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

Model Number	3265135
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2018
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the catheter broke into two pieces when the nurse wanted to do a dressing on a the patient after completing cloxa.No patient injury reported.
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 break is confirmed and was determined to be use related.One 5 fr dual lumen poly per-q-cath was returned for evaluation.An initial visual observation showed use residue throughout the sample.The catheter was observed to be broken between the 11 cm and 12 cm depth markers.A microscopic observation revealed the fracture surfaces to be mostly smooth and lustrous with a section that was granular in texture.A portion of the catheter material in the lustrous section appeared to have been melted and pulled across part of one of the lumens.The edges of the fractures were observed to be mostly rounded.The observed characteristics of the fracture surfaces suggest the catheter came into contact with high heat at some point during use, which caused it to deform and ultimately break.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 the catheter broke into two pieces when the nurse wanted to do a dressing on a the patient after completing cloxa.No patient injury reported.

• Brand Name: POLY RADPICC 5F DUAL-LUMEN POLYURETHANE CATHETER BASIC KIT (135 CM GUIDEWIRE)
• 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: 7536743
• Report Number: 3006260740-2018-01048
• Device Sequence Number: 1432643
• Product Code: LJS
• UDI-Device Identifier: 00801741035104
• UDI-Public: (01)00801741035104
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K034019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2018

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: 3265135
• Device Catalogue Number: 3265135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/19/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 06/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1