MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq0742 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redq0742) have been reported from the same facility.
Event or Problem Description
It was reported the rn had issue with attempt to reposition line by flushing.Rn stated, "line was crossing midline and terminating in left brachiocephalic.When a turbulent flush was done, the line looped in the right subclavian/axillary vein and could not get line to flush at all.I exchanged the line (to the 5fr) to send patient home with long term antibiotics.".
Event or Problem Description
It was reported the rn had issue with attempt to reposition line by flushing.Rn stated, "line was crossing midline and terminating in left brachiocephalic when a turbulent flush was done, the line looped in the right subclavian/axillary vein and could not get line to flush at all.I exchanged the line (to the 5fr) to send patient home with long term antibiotics.".
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.Date of awareness was initially reported incorrectly.Per follow up with sales representative the date of awareness /mdr date of awareness has been updated.The report was submitted within the required timeframe per 21 cfr part 803.

• Brand Name: DOT PROV SP 4F DL MAX
• 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: 9971791
• Report Number: 3006260740-2020-01380
• Device Sequence Number: 2897411
• Product Code: LJS
• UDI-Device Identifier: 00801741134326
• UDI-Public: (01)00801741134326
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2020

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: 07/31/2020
• Device Model Number: N/A
• Device Catalogue Number: S3274108PD
• Device Lot Number: REDQ0742
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1