MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL MAX BARRIER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number S1395108D5

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Infusion or Flow Problem (2964)

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

Event Date 12/20/2020

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 reeu1419 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by health care professional "the picc lot number was reeu1419 and expiration date was 7/31/2021.It was a triple lumen power picc provena solo.I am not sure what the product code is.Placed the picc on (b)(6) 2020.It worked well until about 2 weeks ago.At first the red lumen wouldnt flush at all so we used cath flo on it and it became open and flushed and all ports aspirated blood.This worked well for about a week and then we started having trouble with all the ports but not at the same time.I believe we used cath flo 3 more times to help keep the lines open.This week, i changed the dressing and the caps and found the red port would flush easily but no blood would aspirate.The line looked good on cxr throughout this.I used cath flo and let it sit for 2 hours on the red port with no help.The weird thing was that when i would try and get blood from the red port the white port would have blood return up into line and the end cap.I knew something wasnt right and thought it may be cracked.The patient is getting better and i discussed with dr.Today about just getting rid of the central line and putting in a midline.When i removed the picc i could see the fracture in the line.It was at approximately the 30 cm mark and the line was trimmed to 42 cm.So it was probably up in his subclavian area where it was fractured.I do not believe the patient had any ill effects from this at all." "concomitant therapy: this patient has been treated through his picc with versed, diflucan, dilaudid, lr, lorazepam, fentanyl, lasix, decadron,, zithromax, calcium gluconate, magnesium sulfate, ceftriaxone, ancef ,diuril, nimbex, meropenem, reglan, potassium phosphate, diprivan, remdesivir, rocuronium, sodium phosphate, vancomycin, tracrium, precedex, cardizem, pepcid, ketamine, levophed, protonix, zosyn, vasopressin, diprivan, zemuron.Along with i am sure normal saline.He has been at our hospital for a very long time.".

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, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint a leak in the catheter after difficulty flushing was confirmed.The characteristics observed on the sample are indicative of over-pressurization (burst) damage.The product returned for evaluation was a 5fr t/l powerpicc solo catheter.Residual material from use was seen throughout the sample.The distal end of the catheter was stiff and contained multiple bulges where residual material was caught within the lumen.Reddish-brown residual material was seen occluding the power injectable lumen.A white residual material was seen within the lumen corresponding to the white luer adaptor.A longitudinal split in the tubing was seen at the 30cm depth marking.Tactile evaluation revealed tensile weakness from the 28cm through 35cm depth marking.Microscopic examination of the split revealed it to be 0.292¿ long.The split was slightly curved into a loose s-shape.The edges of the split were finely granular.The split was opened with a dental pick by the investigator to examine the inner lumen.A smaller longitudinal split was observed in the septum wall between the red lumen and the white lumen.When the white and red lumens were flushed, a spraying leak was observed emanating from the split.The gray lumen was patent to infusion with no leaks noted.When an attempt was made to flush the catheter distal of the split site, the catheter was occluded.The occlusion distal of the burst site may have contributed to the failure.Forceful flushing against and occlusion can cause this type of failure.The wall thickness and septum thicknesses were measured at the distal end of the catheter and were all found to meet the device specification.The catheter structure revealed no potential damage/defect related to the manufacturing of the product.The ifu states, ¿catheters that present resistance to flushing and aspiration may be partially or completely occluded.Do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿ h3 other text : evaluation findings are in section h.11.

Event Description

It was reported by health care professional "the picc lot number was reeu1419 and expiration date was 7/31/21.It was a triple lumen power picc provena solo.I am not sure what the product code is.Placed the picc on (b)(6) 2020.It worked well until about 2 weeks ago.At first the red lumen wouldn¿t flush at all so we used cath flo on it and it became open and flushed and all ports aspirated blood.This worked well for about a week and then we started having trouble with all the ports but not at the same time.I believe we used cath flo 3 more times to help keep the lines open.This week, i changed the dressing and the caps and found the red port would flush easily but no blood would aspirate.The line looked good on cxr throughout this.I used cath flo and let it sit for 2 hours on the red port with no help.The weird thing was that when i would try and get blood from the red port the white port would have blood return up into line and the end cap.I knew something wasn¿t right and thought it may be cracked.The patient is getting better and i discussed with dr.Today about just getting rid of the central line and putting in a midline.When i removed the picc i could see the fracture in the line.It was at approximately the 30 cm mark and the line was trimmed to 42 cm.So it was probably up in his subclavian area where it was fractured.I do not believe the patient had any ill effects from this at all."."concomitant therapy: this patient has been treated through his picc with versed, diflucan, dilaudid, lr, lorazepam, fentanyl, lasix, decadron,, zithromax, calcium gluconate, magnesium sulfate, ceftriaxone, ancef ,diuril, nimbex, meropenem, reglan, potassium phosphate, diprivan, remdesivir, rocuronium, sodium phosphate, vancomycin, tracrium, precedex, cardizem, pepcid, ketamine, levophed, protonix, zosyn, vasopressin, diprivan, zemuron.Along with i am sure normal saline.He has been at our hospital for a very long time.".

• Brand Name: POWERPICC PROVENA 5F TL MAX BARRIER
• 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: 11311009
• MDR Text Key: 233245867
• Report Number: 3006260740-2021-00290
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (y/n): N
• PMA/PMN Number: K072230
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S1395108D5
• Device Catalogue Number: S1395108D5
• Device Lot Number: REEU1419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 79