MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 3F SINGLE-LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recz3347 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the device fractured in 2 while inserted in patient.This had to be surgically removed by the operating room on (b)(6) 2020.Line initially placed on (b)(6) 2020" addendum per received email 02/24/2020 - "when the line was removed only 24 of the 41 cm was present.X-ray done and patient taken to surgery to removed the remainder of the line.".
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, 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 break is confirmed and was determined to be use related.One 3 fr single lumen per-q-cath was returned for evaluation.An initial visual observation showed use residue on the returned sample.A break was observed in the catheter between the 11 cm and 12 cm depth markers.Tensile weakness was observed in the proximal catheter segment from about the 4 cm depth marker to the break site at the distal end of this catheter segment.Tensile weakness was observed in almost the entire length of the distal catheter segment.A microscopic observation revealed the fracture surfaces of the catheter to be uneven but mostly flat and granular in texture.The features of the break surfaces of the catheter as well as the tensile weakness observed in the catheter segments indicate the catheter likely broke due to excessive tensile (pulling) force.A lot history review (lhr) of recz3347 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "the device fractured in 2 while inserted in patient.This had to be surgically removed by the or on (b)(6) 2020.Line initially placed on (b)(6) 2020." addendum per received email 02/24/2020- "when the line was removed only 24 of the 41 cm was present.X-ray done and patient taken to surgery to removed the remainder of the line".

• Brand Name: PER-Q-CATH PLUS PICC 3F 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: 9753763
• Report Number: 3006260740-2020-00620
• Device Sequence Number: 2921519
• Product Code: LJS
• UDI-Device Identifier: 00801741035227
• UDI-Public: (01)00801741035227
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 4133110
• Device Lot Number: RECZ3347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR
• Patient Weight: 86