MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PPICC 5F TL TT 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
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 reet2027 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reet2027) have been reported from the same facility.
Event or Problem Description
It was reported that the picc was kinked.It was stated picc was placed in patient using 3cg technology.All lumens drew blood.The team was consulted 2 hours after placement stating that only 1 lumen was able to draw blood.Xray was ordered and line placement was confirmed to be in the correct location.Only 1 lumen from line was able to draw blood despite line being placed in proper location.Line was removed.

• Brand Name: DOT PPICC 5F TL TT 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10872045
• Report Number: 3006260740-2020-20586
• Device Sequence Number: 16779833
• Product Code: LJS
• UDI-Device Identifier: 00801741139512
• UDI-Public: (01)00801741139512
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

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 Model Number: N/A
• Device Catalogue Number: CK000738
• Device Lot Number: REET2027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other