MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM NITINOL GW); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3295355
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) of rebw2280 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.
Event or Problem Description
It was reported that a picc line that was removed from patient, appeared to have a crack in the tubing.This picc line was removed and a new one was reinserted.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 crack in the tubing was confirmed but the exact cause was unknown.The product returned for evaluation was a 5fr d/l powerpicc solo catheter.The sample had been trimmed at the 22cm depth marking and usage residue was seen throughout.Gross visual evaluation of the sample discovered the presence of a circumferential split in the extension tube of the red-luered lumen.The split was located underneath the luer connector by approximately 2mm.Microscopic examination of the damage showed that the fracture surface was rough and granular and the damage regions correlated to points where the extension tube appeared to be adhered to the luer hub.No damage existed in regions of the extension tube which were not tacked to the luer hub.The fracture features at the damage site appeared similar to fatigue damage and flexural fatigue may have been a contributing factor but the damage location and tacking of the extension tube to the luer wall suggest other, unknown, contributing factor(s) may have also been involved.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 rebw2280 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc line that was removed from patient, appeared to have a crack in the tubing.This picc line was removed and a new one was reinserted.No patient injury reported.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DUAL-LUMEN) (70 CM NITINOL GW)
• 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: 7378993
• Report Number: 3006260740-2018-00531
• Device Sequence Number: 11148743
• Product Code: LJS
• UDI-Device Identifier: 00801741028144
• UDI-Public: (01)00801741028144
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• 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 Expiration Date: 03/31/2019
• Device Model Number: 3295355
• Device Catalogue Number: 3295355
• Device Lot Number: REBW2280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 03/28/2018
• 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