MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 5F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER PUNCTUR-GU; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2019
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 recr0488 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the "patient underwent blind catheter placement on (b)(6) 2019 to treat the tubercular meningitis through the infusion of a large amount of mannitol, concentrated potassium and sodium.Following successful puncture, the catheter was delivered to the target position, with 39 cm of it remaining in the body and another 14 cm exposed outside.At 7:15 am on may 4, it was found that the patient's sheet was wetted and notified his/her family and nurse.Upon examination, the nurse found the picc tubing ruptured at the root and the two parts were separated from each other.Immediately notified a surgeon and removed the catheter following the surgeon's advice.Pressed the puncture site, and let the patient lie in a position, with the left head lower while the feet higher, inhaled oxygen, measured blood pressure, let patient keep at rest in bed.Patient in stable condition and continued treatment in hospital".
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter break is confirmed and was determined to be use related.One 5 fr single lumen per-q-cath catheter was returned for evaluation.An initial visual observation showed use residue throughout the returned sample.The catheter was observed to be broken just distal to the strain relief, approximately 2.5 mm proximal to the 0 cm depth marker.Tensile weakness was observed in the catheter beginning from between the 1 cm and 2 cm depth markers to the proximal end of the catheter, at the break site.A microscopic observation revealed the break surfaces of the catheter were mostly smooth and granular in texture; however, some sections of the break surfaces were observed to be angular and uneven.The angular and uneven sections of the break surfaces suggest the catheter was likely damaged by an instrument.This damage likely weakened the catheter and ultimately led to tensile failure of the catheter, as evidence by the flat and granular sections of the break as well as the tensile weakness observed in the catheter leading up to the break.A lot history review (lhr) of recr0468 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the "patient underwent blind catheter placement on april 29, 2019 to treat the tubercular meningitis through the infusion of a large amount of mannitol, concentrated potassium and sodium.Following successful puncture, the catheter was delivered to the target position, with 39 cm of it remaining in the body and another 14 cm exposed outside.At 7:15 am on (b)(6) it was found that the patient's sheet was wetted and notified his/her family and nurse.Upon examination, the nurse found the picc tubing ruptured at the root and the two parts were separated from each other.Immediately notified a surgeon and removed the catheter following the surgeon's advice.Pressed the puncture site, and let the patient lie in a position, with the left head lower while the feet higher, inhaled oxygen, measured blood pressure, let patient keep at rest in bed.Patient in stable condition and continued treatment in hospital.".

• Brand Name: PER-Q-CATH PLUS 5F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER PUNCTUR-GU
• 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: 8692825
• Report Number: 3006260740-2019-01629
• Device Sequence Number: 11285492
• Product Code: LJS
• UDI-Device Identifier: 00801741074929
• UDI-Public: (01)00801741074929
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2019

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: 4135115
• Device Lot Number: RECR0468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1