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	12/01/2017
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 rebt1982 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the nurse that she found the patient's bed was wet; found the implicated picc leaking.The nurse then allegedly clamped the red-lumen and the leaking stopped.Catheter was removed and a new catheter was re-inserted.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 leak was confirmed and the cause was determined to be use related.One 5fr d/l poly radpicc was returned for investigation.The bifurcation was yellow in color, which confirms that the sample was used.Tape residue was observed on the extension legs.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 lumens were patent to infusion, and a leak was observed at the tear.It appeared that the catheter was manipulated during use, which caused the material to tear.The discoloration in the material may have been a contributing factor.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) of rebt1982 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the nurse that she found the patient's bed was wet; found the implicated picc leaking.The nurse then allegedly clamped the red-lumen and the leaking stopped.Catheter was removed and a new catheter was re-inserted.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: 7154581
• Report Number: 3006260740-2017-02337
• Device Sequence Number: 10802604
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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
• Device Lot Number: REBT1982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/29/2017
• Supplement Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 62