MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
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 refr2350 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "i was placing a 3 french groshong on a 5 week old.I was inspecting the picc prior to threading it through the micro introducer and noticed some very fine small fibers on the end of the picc.My thought was that it was possibly from the gauze.I did leave the picc in the plastic casing until the vein was accessed so i don't know how something would have gotten on it.I tend to leave it in the casing so it doesn't flop around and become unsterile, then i remove it and do a more thorough inspection after the micro introducer is in place.At any rate, i did not place that picc line.We opened another kit and placed the second picc as it had no issues noted on inspection.I checked on the patient today, at 24 hours post placement, and he is doing well.No complications with the picc.".

• Brand Name: GROSHONG CATHETER WITH SHERLOCK TIP LOCATION SYSTEM (TLS) STYLET
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14190391
• Report Number: 3006260740-2022-01461
• Device Sequence Number: 17282395
• Product Code: LJS
• UDI-Device Identifier: 00801741036057
• UDI-Public: (01)00801741036057
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K063240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2022

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: 9717308
• Device Lot Number: REFR2350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown