MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POLY MIDLINE 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER); INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2017
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 following were reviewed as part of this investigation: patient severity, trend 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 leaking midline catheter was confirmed through video footage, but the cause could not be determined since the physical sample was not returned for evaluation.The video is 5 seconds long and shows a midline catheter.The words ¿poly midline¿ were visible on the white hub.It appeared that the catheter had been inserted into the body.Blood residue is shown on a drape below the insertion site.A length of purple material was shown to the left of the catheter which is assumed to be the tourniquet.The location of insertion is unclear throughout the video.It was observed at around the 2 second mark that a clear fluid is escaping from the catheter at the junction between the proximal end of the white molded hub and the extension leg.The tubing proximal to the hub is not relaxed but appears taut at about a 30° angle upward from horizontal.A clamp is seen proximal to the hub which is not clamped down.No statlock is seen on the device.In conclusion, the complaint alleging a leaking midline is confirmed by video evidence, but the cause could not be determined without the physical sample.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.
Event or Problem Description
It was reported by the facility that the catheter leaked during insertion while flushing.

• Brand Name: BARD POLY MIDLINE 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN) (WITH MICROINTRODUCER)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6504548
• Report Number: 3006260740-2017-00442
• Device Sequence Number: 10798757
• Product Code: LJS
• UDI-Device Identifier: 00801741037665
• UDI-Public: (01)00801741037665
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K001901
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2017

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 Model Number: N/A
• Device Catalogue Number: 4154108D
• Device Lot Number: REBN0859 (INVAILD)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1