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	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that leak noted to purple lumen by bedside nurse on (b)(6)2023 at 1857.Additional information received 06/19/2023 patient is a previously healthy male with pancytopenia and peripheral blasts admitted to the picu with continued bleeding and pancytopenia, work up consistent with acute promyelocytic leukemia.Initiated on chemotherapy (b)(6) 2023 per aaml1331 protocol.This event directly involved a patient.The event did not involve an urgent/life threatening medical situation.Patient required new picc line placement immediately to avoid any interruption in chemotherapy plan.Patient required an additional sedation event for another picc line insertion.This rn does is not aware of any medication interruption.New picc line placed as soon as possible.
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.
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 is unconfirmed as the alleged problem was not found in the returned sample.One 4 fr dual lumen powerpicc provena catheter was returned for evaluation.An initial visual observation showed use residue on the returned sample.The sample was flushed and pressurized with a 12 ml syringe of water.No leaks were found, and the catheter was found to be patent to infusion.A kink was observed in the catheter tubing near the 24 cm depth marker, but no leaks, splits, fractures, or other damage were found on the returned catheter.
Event or Problem Description
It was reported by customer that leak noted to purple lumen by bedside nurse on (b)(6) 2023 at 1857.Additional information received 06/19/2023 : patient is a previously healthy male with pancytopenia and peripheral blasts admitted to the picu with continued bleeding and pancytopenia, work up consistent with acute promyelocytic leukemia.Initiated on chemotherapy (b)(6) 2023 per aaml1331 protocol.This event directly involved a patient.The event did not involve an urgent/life threatening medical situation.Patient required new picc line placement immediately to avoid any interruption in chemotherapy plan.Patient required an additional sedation event for another picc line insertion.This rn does is not aware of any medication interruption.New picc line placed as soon as possible.

• 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: 17221277
• Report Number: 3006260740-2023-02681
• Device Sequence Number: 14209150
• 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): 09/06/2023

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 Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S3274108PD
• Device Lot Number: REGQ1410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• 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: 09/06/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: Other
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Hispanic