MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV SP 4F DL MAX; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2023
Type of Reportable Event	Malfunction
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 the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by customer that leak noted from purple plastic hub by bedside nurse (b)(6) 2023 additional information received 06/19/2023 patient has history of aml who presents due to fatigue and hemoptysis with labs significant for severe thrombocytopenia.He received all previous care in mexico besides recent admission at osh and further research will need to be made into prior treatments.S/p bronchoscopy, biopsy, lp, intrathecal cytarabine.Fever s/p procedures on 6/9, spiked fever 6/10 am.Continues cefepime and linezolid.Plan to repeat blood and urine cultures after 24 hours since last draw if patient remains febrile.Plan to replace picc tomorrow due to hole in one of the lines, functionally patient only has single lumen picc.This event directly involved a patient.It did not involve an urgent/life threatening medical situation.Patient required placement of another picc line which always runs the risk of introduction infection.This rn is not aware of any medication interruption.New picc line was placed immediately.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of leakage at the luer adapter was confirmed; however, the root cause was not identified.The product returned for evaluation was one 4fr d/l powerpicc provena catheter.Light usage residues were observed and needleless injection caps were attached to both luer adapters.An attempt to infuse water through the sample using a 12ml syringe revealed both lumens to be patent to infusion and aspiration; however, during pressurization, a leak was observed at the interface between the purple luer adapter and the needleless injection cap.No leaks were observed when pressurizing the purple luer adapter using various non-complainant accessories.Microscopic inspection of the purple luer adapter did not reveal any damage or deformity.Inspection of the leaking injection cap also did not reveal any damage or deformity.The observed leak appeared to caused by incompatibility between the catheter and the injection cap; however, no damage or deformity was discovered.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by customer that leak noted from purple plastic hub by bedside nurse (b)(6) 23.Additional information received (b)(6) 2023 patient has history of aml who presents due to fatigue and hemoptysis with labs significant for severe thrombocytopenia.He received all previous care in mexico besides recent admission at osh and further research will need to be made into prior treatments.S/p bronchoscopy, biopsy, lp, intrathecal cytarabine.Fever s/p procedures on 6/9, spiked fever 6/10 am.Continues cefepime and linezolid.Plan to repeat blood and urine cultures after 24 hours since last draw if patient remains febrile.Plan to replace picc tomorrow due to hole in one of the lines, functionally patient only has single lumen picc.This event directly involved a patient.It did not involve an urgent/life threatening medical situation.Patient required placement of another picc line which always runs the risk of introduction infection.This rn is not aware of any medication interruption.New picc line was placed immediately.

• Brand Name: DOT PROV SP 4F DL 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17234672
• Report Number: 3006260740-2023-02700
• Device Sequence Number: 5642969
• Product Code: LJS
• UDI-Device Identifier: 00801741134326
• UDI-Public: (01)00801741134326
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• 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): 12/14/2023

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 Model Number: N/A
• Device Catalogue Number: S3274108PD
• Device Lot Number: REHN2442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: 15 YR
• Patient Sex: Male
• Patient Weight: 47 KG
• Patient Ethnicity: Hispanic
• Patient Race: White