MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POLY MIDLINE, 4F SL MAX; INTRAVASCULAR CATHETER

Catalog Number	4154108D
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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rear0842 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
On 7/26/2016- per sales representative, user facility reported that a midline catheter leaked after two days and was removed and replaced.On 08/08/2016 - facility contact reported that the midline leak was located "outside/inside the lumen".Contact stated that he did not nick the skin but noticed after a few days that the bio patch became wet after the patient received iv antibiotics.He stated that when the catheter was flushed, there was a leak coming from the exit site.He reported that when he was changing the dressing and flushed the line, "a sudden gush of blood came out from the exit site".He reported he inserted this line.The catheter was discontinued and he noticed the catheter was "crooked, not straight." on 08/08/2016 - facility contact reported that the catheter was placed in the upper arm and never in the ac.They use the basilica or cephalic vein.

• Brand Name: POLY MIDLINE, 4F SL MAX
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5886834
• Report Number: 3006260740-2016-00437
• Device Sequence Number: 18963157
• Product Code: LJS
• UDI-Device Identifier: 00801741037665
• UDI-Public: (01)00801741037665(17)171028(10)REAR0842
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

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: 10/28/2017
• Device Catalogue Number: 4154108D
• Device Lot Number: REAR0842
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1