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
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
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 difficulty removing a stylet is confirmed and was determined to be use related.One 4 fr per-q-cath with a stiffening stylet and one excalibur introducer sheath were returned for evaluation.An initial visual observation showed blood residue throughout the returned samples.The stiffening stylet was returned outside of the catheter, but still within the t-lock.The stylet was observed to be unraveled proximal to the t-lock, and the core wire of the stylet was observed to be broken and protruding out of the silicone membrane of the t-lock.A microscopic observation revealed the break site of the core wire was tapered and the fracture surface was mostly smooth with a granular texture, which is evidence of a tensile break most-likely caused by excessive pulling force on the stylet.The product ifu states: ¿never use force to remove the stylet¿ and ¿flush the catheter with sterile normal saline or heparinized saline prior to use.Catheter stylet must be wetted prior to stylet repositioning or withdrawal.¿ a lot history review (lhr) of rebz0505 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guide wire got stuck.The attempt happened in the upper limb guided by doppler ultrasound.(b)(6) 2019 - returned wire is broken.

• 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: 8453842
• Report Number: 3006260740-2019-00696
• Device Sequence Number: 2978003
• 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,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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 Expiration Date: 11/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 4134105
• Device Lot Number: REBZ0505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR