MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SOLO 3F SL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1193108D
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
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 redx4556 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on a 3 french single lumen picc the markings indicating placement are wearing off after a few dressing changes.The zero on the picc line has almost worn off.It was stated that this is a concern, as it becomes difficult to ensure that a picc line is still central with dressing changes.
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.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of worn out depth markings is confirmed but the exact cause is unknown.One photo sample of a 3 fr sl powerpicc solo catheter was provided for evaluation.The catheter is shown within patient use and is secured by a statlock securement device.A short section of the catheter shaft is visible between the winged hub and insertion site; however, the exact length could not be determined from the image.No depth markings are visible on the catheter surface shown.Sections of the white printing on the winged hub are faded.The event description indicates the depth markings begin to fade after undergoing multiple dressing changes.Based on the image provided and description of the reported event, possible contributing factors include exposure time to cleaning agents and use of incompatible chemicals.Since the depth markings were not visible on the catheter shaft shown in the image, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that on a 3 french single lumen picc the markings indicating placement are wearing off after a few dressing changes.The zero on the picc line has almost worn off.It was stated that this is a concern, as it becomes difficult to ensure that a picc line is still central with dressing changes.

• Brand Name: DOT PROV SOLO 3F SL MAX
• 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: 10830293
• Report Number: 3006260740-2020-20487
• Device Sequence Number: 14160412
• Product Code: LJS
• UDI-Device Identifier: 00801741130359
• UDI-Public: (01)00801741130359
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021

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: 12/31/2020
• Device Model Number: S1193108D
• Device Catalogue Number: S1193108D
• Device Lot Number: REDX4556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 03/12/2021
• 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