MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6FR TL PP SOLO MB KIT; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2017
Type of Reportable Event	Malfunction
Additional 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 rebq1266 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported by the facility that they had a cracked valve.Update 06/14/17 - additional information received from facility: they reported that the white lumen on the triple lumen power picc broke and disintegrated at the valve site.
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 a cracked luer connector was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was two pieces of the white cap for a solo connector.The remaining connector and associated catheter were not returned for evaluation.The connector had split into multiple pieces and the fracture planes were primarily oriented in the longitudinal direction.Microscopic examination of the fracture surfaces of revealed two voids within the wall of the connector.The fracture surfaces, outside the voids, were rough and granular in nature.The voids 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.The manufacturing facility evaluated the returned sample and states: the complaint for ¿cracked valve¿ is confirmed according the evaluation the sample received which showed valve part cracked of the lumen white; showed two 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 event review was opened to track this issue.A lot history review (lhr) of rebq1266 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they had a cracked valve.06/14/2017 - additional information received from facility: they reported that the white lumen on the triple lumen power picc broke and disintegrated at the valve site.

• Brand Name: 6FR TL PP SOLO MB KIT
• Common Device Name: PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6692566
• Report Number: 3006260740-2017-00998
• Device Sequence Number: 13887117
• Product Code: LJS
• UDI-Device Identifier: 00801741034749
• UDI-Public: (01)00801741034749
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: 1396108D
• Device Lot Number: REBQ1266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 10/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1