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	01/17/2018
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of cracked catheter is confirmed, but cause is unknown.One photograph was returned for evaluation.The photograph appears to capture the bifurcation of a 5 fr poly per-q-cath within transparent dressing including a statlock.It appears that the bifurcation has split at the proximal intersection of each suture wing and the bifurcation body.As the damage to the catheter is apparent, but the cause is not discernible, the complaint is confirmed as cause unknown.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 picc was inserted on (b)(6) 2017.They found a crack at the hub on (b)(6) 2018 and they had to reinsert a new picc.There were no reports of patient injury.
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 leak was confirmed and the cause was determined to be use related.One 5 fr d/l poly radpicc was returned for investigation.The catheter revealed evidence of use.The catheter extended 43.5cm from the distal end of the bifurcation.The bifurcation was attached to a used statlock stabilization device.Tape residue was observed on the catheter between the bifurcation and the 6cm depth mark.The 5 and 6 cm depth marks were observed on the catheter.A 2mm tear was observed at the proximal end of the wing on the red lumen side of the catheter.A microscopic examination revealed that the adjoining surfaces between the wing and bifurcation were rough and granular, which is indicative of a tear.A functional test revealed that the lumen with the gray connector was patent to infusion.When water was flushed through the lumen with the red connector, fluid leaked from the tear at the bifurcation and wing.The section of tubing distal to the leak site was occluded with blood residue.It appeared that the catheter was manipulated during use, which caused the material to tear.Due to the evidence of use, it appeared that the tear developed over time.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.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 picc was inserted on (b)(6) 2017.They found a crack at the hub on (b)(6) 2018 and they had to reinsert a new picc.There were no reports of patient injury.

• 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: 7311561
• Report Number: 3006260740-2018-00355
• Device Sequence Number: 16169082
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 04/26/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1