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

Model Number	N/A
Medical Device Problem Codes	Suction Problem (2170); Material Deformation (2976)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that, "on (b)(6) 2023 the line was occluded and would not flush or draw.When patient's arm was lifted, the line would flush and draw.X-ray showed kink near insertion site.Line retracted 1 cm and catheter drew and flushed with ease.On (b)(6) 2023, picc (same line as before) occluded.Picc was retracted 1 cm.Red lumen with brisk blood return flushes easily, purple lumen flushes with mild resistance and had no blood return.Patient also complaining of pain in left shoulder.Axillary arm circumference noted to be 3cm greater than on date of insertion.An ultrasound was taken the same day and showed l brachial vein thrombus - no noted flow around picc in left cephalic vein but proximal and distal portions of left cephalic vein appear patent.The catheter was removed and replaced.Per clinician, the event did not occur during an urgent or life-threatening medical situation and did not cause a clinically significant delay in treatment.".
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 manufacturer has received a sample and will evaluate.Results are expected soon.
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 complaint of difficulty with infusion and aspiration for a powerpicc catheter is confirmed.One 4 fr d/l powerpicc was returned for evaluation.An initial visual observation showed use residues throughout the returned catheter, and an observation of the distal end of the catheter revealed one of the lumens to appear to be occluded with blood residues.A functional test of attempting to infuse water into each lumen revealed the red lumen to be patent to infusion.During the functional test, it was observed that the purple lumen was patent to infusion; however, infusion was difficult, and the water exiting the purple lumen side of the catheter split into three small streams.A functional test for aspiration was performed with water using the 12 ml syringe for each lumen revealing each lumen to aspirate while the purple lumen was observed to aspirate at a slower rate.A microscopic observation revealed the terminal end of the catheter on the purple lumen side to be occluded with much blood use residues.The catheter appeared to be stuck to itself with the blood remains, causing difficulty with infusion and aspiration on the purple lumen side of the catheter.It appeared as though technique for trimming the catheter may have contributed to the deformation of the purple lumen of the catheter.The red lumen distal end of the catheter appeared to have some clear residues on the exit site, but it did not appear to be causing any aspiration or infusion difficulties.Based on the returned sample analysis, the complaint of difficulty infusing and aspirating a powerpicc catheter is confirmed.Insertion techniques and maintenance of the catheter may have contributed to the failure of the device as well as possible catheter trimming techniques.
Event or Problem Description
It was reported by the customer that, "on 4/7/23 the line was occluded and would not flush or draw.When patient's arm was lifted, the line would flush and draw.X-ray showed kink near insertion site.Line retracted 1 cm and catheter drew and flushed with ease.On 4/10/23, picc (same line as before) occluded.Picc was retracted 1 cm.Red lumen with brisk blood return flushes easily, purple lumen flushes with mild resistance and had no blood return.Patient also complaining of pain in left shoulder.Axillary arm circumference noted to be 3cm greater than on date of insertion.An ultrasound was taken the same day and showed l brachial vein thrombus - no noted flow around picc in left cephalic vein but proximal and distal portions of left cephalic vein appear patent.The catheter was removed and replaced.Per clinician, the event did not occur during an urgent or life-threatening medical situation and did not cause a clinically significant delay in treatment.".

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16868252
• Report Number: 3006260740-2023-01697
• Device Sequence Number: 5832988
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REGZ1032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 50 KG