MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY 135 CM GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "getting iv medication in picc line started leaking at end of infusion.Red lumen leaking at hub connection.Line clamped cleaned with alcohol and gauze and taped applied." add information received 04/19/2022: was the product used on a patient? yes.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.- no.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez4075 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "getting iv medication in picc line started leaking at end of infusion.Red lumen leaking at hub connection.Line clamped cleaned with alcohol and gauze and taped applied." add information received 04/19/2022: was the product used on a patient? yes was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.- no.
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, complaint and lot history, applicable previous investigation(s), applicable manufacturing records, returned physical sample, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of leakage from the catheter was confirmed.The product returned for evaluation was a 5fr d/l powerpicc catheter.The sample contained evidence of use and a gross visual assessment found that a partial split in the extension tubing existed at the distal edge of the red luer.Kink impressions were seen on the extension tubing at the edge of the purple luer but no holes in that extension leg tubing were seen.Microscopic examination of the extension tubing damage found linear striation-like patterns which extended through the entire thickness of the tubing.This damage is characteristic of repeated kinking of the tube, called flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the tubing and may gradually form a crack(s) in the tubing.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product h3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY 135 CM GUIDEWIRE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14315925
• Report Number: 3006260740-2022-01655
• Device Sequence Number: 5223529
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 3275335
• Device Lot Number: REEZ4075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown