MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVPPSOLO 4FDL MBP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer picc was placed around 0730 by rn.No issues with picc placement.Rn got a call around 1700 from the icu nurse stating issues with the new picc.Stated that when he went to flush one of the picc lumens after a blood draw, the initial 5cc went in but the rest of the saline and sluggish blood started coming out of the second lumen.When placement rn went to assess the line, she stated the same thing happening to her.She flushed the purple lumen just find with no issues, then aspirated and flushed again with the second flush when blood started coming out of the other lumen.No leaking was noted.The picc was removed and leaking/possible fracture is somewhere in the middle of the picc but unable to locate.A new line placed.Patient was receiving q4hr blood draws.Rn stated no issues up until the 3rd lab draw.No patient injury.No other information was provided.
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 a leak was confirmed and was determined to be manufacturing related.The product returned for evaluation was a 4fr dual lumen powerpicc solo catheter with two needleless injection caps.Use residue was observed on the sample.Two complete breaks were observed in the catheter shaft, one was at the 10cm depth marking and the other was at the 28cm depth marking.Microscopic inspection of the break surfaces revealed features that were consistent with a sharp instrument.An attempt to flush the purple lumen with water using 12ml syringe revealed the catheter was patent to infusion and aspiration.When the catheter was pressurized, water leaked out of the red lumen.An attempt to pressurize different locations of the catheter shaft also resulted in the red lumen leaking water.The connection between lumens was determined to be within the molded joint.The molded joint was dissected which revealed a channel connecting both lumens, caused by a void in the molded material.The connection between the lumens within the molded joint likely occurred during device manufacture.This complaint will be forwarded to the manufacturing site for further evaluation.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer picc was placed around 0730 by rn.No issues with picc placement.Rn got a call around 1700 from the icu nurse stating issues with the new picc.Stated that when he went to flush one of the picc lumens after a blood draw, the initial 5cc went in but the rest of the saline and sluggish blood started coming out of the second lumen.When placement rn went to assess the line, she stated the same thing happening to her.She flushed the purple lumen just find with no issues, then aspirated and flushed again with the second flush when blood started coming out of the other lumen.No leaking was noted.The picc was removed and leaking/possible fracture is somewhere in the middle of the picc but unable to locate.A new line placed.Patient was receiving q4hr blood draws.Rn stated no issues up until the 3rd lab draw.No patient injury.No other information was provided.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20156843
• Report Number: 3006260740-2024-04991
• Device Sequence Number: 4235344
• Product Code: LJS
• UDI-Device Identifier: 00801741155208
• UDI-Public: (01)00801741155208(11)240528(17)250831(10)REJR0467
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: S1294108D5
• Device Lot Number: REJR0467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 01/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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 Age: 55 YR
• Patient Sex: Male