MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR T/L POWERPICC SOLO, 135 CM NITINOL; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number 3396335

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebn1413 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the white hub of the triple lumen picc line, was brittle and broke in pieces when picc insertion was completed in the di and the picc was going to be flushed for a post insertion check.The patient procedure was delayed 30 min , and the picc line needed to be exchanged and 2nd picc tray opened.No patient injury was reported.

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 a cracked luer connector was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was a 6fr t/l powerpicc solo catheter.The white solo connector cap contained a longitudinally-aligned crack which traversed the length of the cap.A connector section which contained luer threads had broken off and was not returned for evaluation.The cap crack was forced open at bas in order to inspect the inner fracture surface.Microscopic examination of the fracture surfaces revealed a void within the wall of the connector.The fracture surfaces, outside the void, were rough and granular in nature.The void within the connector, and apparent brittle nature of the break, suggest that this issue may be related to the manufacturing or molding process of the white cap.The sample was sent to the manufacturing facility for further review.Manufacturing evaluation: the complaint for ¿valve cracked¿ is confirmed according the evaluation the sample received which showed valve part cracked of the lumen white; showed three bubbles within valve, maybe these are caused by the incorrect molding process, leading to valve breakage.This condition cause leak in the device.Therefore the cause for this complaint is manufacturing related.An internal event was opened for the tracking of this issue.A lot history review (lhr) of rebn1413 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the white hub of the triple lumen picc line, was brittle and broke in pieces when picc insertion was completed in the di and the picc was going to be flushed for a post insertion check.The patient procedure was delayed 30 min , and the picc line needed to be exchanged and 2nd picc tray opened.No patient injury was reported.

• Brand Name: 6 FR T/L POWERPICC SOLO, 135 CM NITINOL
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6685943
• MDR Text Key: 79238621
• Report Number: 3006260740-2017-00967
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741028489
• UDI-Public: (01)00801741028489
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 10/20/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: 3396335
• Device Catalogue Number: 3396335
• Device Lot Number: REBN1413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1