MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recu0693 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported picc was inserted in patient, began leaking when flushing.Picc was pulled and another picc placed, no harm to patient.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be use related.One 2 fr per-q-cath with a t-lock and stylet inserted was returned for evaluation.An initial visual observation showed no blood residue on the returned catheter.The catheter was flushed with a 12 ml syringe of water and a leak was observed just distal to the 5 cm depth marker.A microscopic observation revealed a large diagonal split at the leak site.The edges of the split were observed to be rough and the fracture surface was observed to be smooth and granular in texture.Additional damage was observed on the inner wall of the catheter near the split.The characteristics of the damage observed on and within the returned catheter indicate the damage was most-likely caused by manipulation of the stiffening stylet within the catheter prior to flushing the catheter, compression of the catheter with the stylet still inserted, and/or rapid or forceful withdrawal of the stylet from the catheter.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¿ and ¿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.¿ an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported picc was inserted in patient, began leaking when flushing.Picc was pulled and another picc placed, no harm to patient.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET INTERMEDIATE TRAY
• 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: 8777152
• Report Number: 3006260740-2019-01898
• Device Sequence Number: 1832397
• Product Code: LJS
• UDI-Device Identifier: 00801741035210
• UDI-Public: (01)00801741035210
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2019

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: 4132100
• Device Lot Number: RECU0693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1