MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PPICC SOLO PROVENA 4F DL 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number CK000409

Device Problems Device Dislodged or Dislocated (2923); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reev1496 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "picc place 12/23 ck000409a 4 french dual lumen powerpicc provena solo, lot reev1496 out 0 cm.Dressing change 12/30 no documentation of external length.Dressing change again 12/31 and it was out 3 cm.Issues presented later that day.No product available for return.".

Event Description

It was reported "picc place 12/23 ck000409a 4 french dual lumen powerpicc provena solo, lot reev1496 out 0 cm.Dressing change 12/30 no documentation of external length.Dressing change again 12/31 and it was out 3 cm.Issues presented later that day.No product available for return.".

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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheter migration out of the body was inconclusive due to the sample condition.One x-ray of an upper arm and partial chest was returned for evaluation.The proximal end of a catheter was seen in the x-ray.The catheter appeared to have a radiused bend near the molded suture hub and then a sharper bend in the catheter shaft.The images were forwarded to a radiologist consultant for further review.No evidence of catheter migration was visible in the x-ray.However, there were apparent kinks in the catheter tubing near the skin surface and as the tubing enters the vein.This could be actual kinks, or it could be caused by the angle at which the image was taken.Possible contributing factors for the reported failure mode could include device placement (e.G.Catheter bunching during placement), patient movement, or improper device securement.H3 other text : evaluation findings are in section h.11.

• Brand Name: DOT PPICC SOLO PROVENA 4F DL 3CG
• Type of Device: 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: 11379777
• MDR Text Key: 234957323
• Report Number: 3006260740-2021-00488
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741096280
• UDI-Public: (01)00801741096280
• Combination Product (y/n): N
• PMA/PMN Number: K180548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Model Number: CK000409
• Device Catalogue Number: CK000409A
• Device Lot Number: REEV1496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Manufacturer Received: 01/27/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other