MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC; 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 Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recx2383 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the nurse that after removing the guidewire and performing salinization of the catheter, he could observe a leak.
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak in the per-q-cath picc was confirmed, and the damaged was determined to be related to use of the device.One 4fr single-lumen (s/l) per-q-cath picc was returned for investigation.The 4fr tubing extended to the 60cm depth mark.The stylet and t-lock extension set had been removed from the catheter.The t-lock extension set was not returned for investigation.Two stylet wires were returned for investigation.The black tab was not attached to one stylet and the coil wire was stretched over a portion of the core wire.Multiple bends were observed in each stylet wire.The damage observed on the stylet wires appeared to be related to the reported leak.A functional test revealed fluid leaking from a 4mm longitudinal split in the catheter that was positioned between the zero mark and the 1cm depth mark.The damage within the catheter was greater than what was observed on the external surface of the tubing.This type of damage occurs when the stylet is repositioned within the picc without flushing the catheter or using force to remove the stylet.The product ifu states, ¿flush the catheter with sterile normal saline or heparinized saline prior to use.Catheter stylet must be wetted prior to stylet repositioning or withdrawal.¿ the ifu also cautions, ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.Once the stylet is out, advance the catheter into the desired position.¿.A lot history review (lhr) of recx2383 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the nurse that after removing the guidewire and performing salinization of the catheter, he could observe a leak.

• Brand Name: PER-Q-CATH PLUS PICC 4F SINGLE-LUMEN PICC
• 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: 9112782
• Report Number: 3006260740-2019-02814
• Device Sequence Number: 13949375
• Product Code: LJS
• UDI-Device Identifier: 00801741074875
• UDI-Public: (01)00801741074875
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 4134105
• Device Lot Number: RECX2383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1