MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC TRAY; 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)
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 recx1506 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recx1506) have been reported from the same facility in (b)(4).
Event or Problem Description
It was reported that on (b)(6) a client reported that their picc had allegedly "broken".They stated that it just allegedly happened, no untoward actions happened on their part (scissors, etc).It was inserted at lgh on (b)(6) and the lot # was recx1506.Patient was sent to vgh er where they removed it (and threw it away sadly) and the client had a new one inserted the next day.Patient outcome/status reported as stable.
Event or Problem Description
It was reported that on march 10th a client reported that their picc had allegedly "broken".They stated that it just allegedly happened, no untoward actions happened on their part (scissors, etc).It was inserted at lgh on march 4th and the lot # was recx1506.Patient was sent to vgh er where they removed it (and threw it away sadly) and the client had a new one inserted the next day.Patient outcome/status reported as stable.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter was confirmed, and the cause appeared to be use-related.The product returned for evaluation was one 5fr s/l powergroshong catheter.Usage residues were observed throughout the sample.The sample terminated at the distal end of the molded joint.The catheter shaft was not returned for evaluation.Microscopic inspection of the break site revealed a coarsely granular fracture surface.Tactile inspection of the sample revealed tensile weakness and material necking at the proximal end of the extension tubing.The fracture features, tensile weakness and necking suggested that the catheter tubing material failed under tensile (pulling) stress.The location of the break suggested that catheter securement and maintenance technique may have contributed.A lot history review (lhr) of recx1506 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (recx1506) have been reported from the same facility in canada.
Event or Problem Description
It was reported that on march 10th a client reported that their picc had allegedly "broken".They stated that it just allegedly happened, no untoward actions happened on their part (scissors, etc).It was inserted at lgh on march 4th and the lot # was recx1506.Patient was sent to vgh er where they removed it (and threw it away sadly) and the client had a new one inserted the next day.Patient outcome/status reported as stable.
Additional Manufacturer Narrative
Corrected data: mdr classification changed to malfunction.

• Brand Name: POWERGROSHONG 5F SINGLE-LUMEN SILICONE CATHETER WITH MICROINTRODUCER BASIC 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: 8533460
• Report Number: 3006260740-2019-01114
• Device Sequence Number: 2457806
• Product Code: LJS
• UDI-Device Identifier: 00801741028533
• UDI-Public: (01)00801741028533
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K063848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2019

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 Model Number: N/A
• Device Catalogue Number: 7818518
• Device Lot Number: RECX1506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Event Location: Home
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/15/2019; 06/18/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 06/11/2019; 06/28/2019
• 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: Hospitalization