MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV 4F DL FULL 3CG; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	S1274108
Health Effect - Clinical Code	Underdose (2542)
Date of Event	09/17/2017
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 rebt0755 showed no other similar product complaint(s) from this lot number.Device not returned yet.
Event or Problem Description
It was reported by the facility that the picc was placed on (b)(6) 2017.On (b)(6) 2017, it was disconnected as a leak was found beneath the red hub and extension juncture.Patient was on "vasosupressors" and couldn't keep his blood pressure up.When tracing the iv tubing back to the picc, it was noted that the medication was leaking onto the bed and the patient wasn't receiving medication.
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 bard access systems for evaluation.Based on the description of the reported event, possible contributing factors include sharp instrument contact, tensile damage and material fatigue; 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 rebt0755 showed no other similar product complaint(s) from this lot number.Device not returned yet.
Event or Problem Description
It was reported by the facility that the picc was placed on (b)(6) 2017.On (b)(6) 2017, it was disconnected as a leak was found beneath the red hub and extension juncture.Patient was on "vasosupressors" and couldn't keep his blood pressure up.When tracing the iv tubing back to the picc, it was noted that the medication was leaking onto the bed and the patient wasn't receiving medication.

• Brand Name: DOT PROV 4F DL FULL 3CG
• 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: 7162840
• Report Number: 3006260740-2017-02364
• Device Sequence Number: 13925872
• Product Code: LJS
• UDI-Device Identifier: 00801741130120
• UDI-Public: (01)00801741130120
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• 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 Catalogue Number: S1274108
• Device Lot Number: REBT0755
• 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: 01/03/2018
• 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