MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 4F DL MAX TLS; 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 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 rebq2477 showed two other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
The facility reported to the sales representative that there was a leak in the catheter at the red hub/extension leg.No other information was provided.There was no harm to the patient reported.
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 leak was inconclusive because no sample was returned to bas for evaluation.Based on the description of the reported event, possible contributing factors include sharp instrument damage, material fatigue, and tensile failure; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Consequently, this complaint is inconclusive at this time.A lot history review (lhr) of rebq2477 showed two other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
The facility reported to the sales representative that there was a leak in the catheter at the red hub/extension leg.No other information was provided.There was no harm to the patient reported.

• Brand Name: DOT PROV 4F DL MAX TLS
• 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: 7031661
• Report Number: 3006260740-2017-02023
• Device Sequence Number: 16378476
• Product Code: LJS
• UDI-Device Identifier: 00801741130441
• UDI-Public: (01)00801741130441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: S9274108D
• Device Lot Number: REBQ2477
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1