MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 2FR SL W/O GW BULK NON; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer technical area, "picc ruptured spontaneously after 8 days of use in the nb, while infusing intravenous hydration.It ruptured on the outside, was removed immediately, neonatologist informed." 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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
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.
Event or Problem Description
It was reported by the customer technical area, "picc ruptured spontaneously after 8 days of use in the nb, while infusing intravenous hydration.It ruptured on the outside, was removed immediately, neonatologist informed." no other information was provided.Additional information received 05/29/2023: the break occurred on the outside.There was no harm to the patient, but it was necessary to remove this picc and place another one.Therefore, there was a need for a new procedure.There was no need for medical/surgical intervention, only picc replacement.Intravenous hydrochloride was being infused.There was leakage of this intravenous hydration.Additional information received 26 june 2023: the professionals who handle this material have a specific course certificate for this purpose.Only nurses with this certification handle the picc.The product was used in accordance with the conditions of use.There was no traction movement during catheter insertion.
Event or Problem Description
It was reported by the customer technical area, "picc ruptured spontaneously after 8 days of use in the nb, while infusing intravenous hydration.It ruptured on the outside, was removed immediately, neonatologist informed." no other information was provided.Additional information received 05/29/2023: the break occurred on the outside.There was no harm to the patient, but it was necessary to remove this picc and place another one.Therefore, there was a need for a new procedure.There was no need for medical/surgical intervention, only picc replacement.Intravenous hydrochloride was being infused.There was leakage of this intravenous hydration.Additional information received 26 june 2023: the professionals who handle this material have a specific course certificate for this purpose.Only nurses with this certification handle the picc.The product was used in accordance with the conditions of use.There was no traction movement during catheter insertion.
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 catheter break is confirmed but the exact cause is unknown.One photo sample of a 2 fr perqcath picc catheter was provided for evaluation.The catheter is shown within a plastic bag.The catheter appears to be fractured at the region extending from the hub and strain-relieve.Gauze dressing and evidence of use was visible.The characteristics of the fracture surfaces could not be closely inspected from the image provided.Since a complete break in the catheter was observed, the complaint is confirmed; however, the exact contributing factors remain unknown.
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer technical area, "picc ruptured spontaneously after 8 days of use in the nb, while infusing intravenous hydration.It ruptured on the outside, was removed immediately, neonatologist informed." no other information was provided.Additional information received 05/29/2023: the break occurred on the outside.There was no harm to the patient, but it was necessary to remove this picc and place another one.Therefore, there was a need for a new procedure.There was no need for medical/surgical intervention, only picc replacement.Intravenous hydrochloride was being infused.There was leakage of this intravenous hydration.

• Brand Name: 2FR SL W/O GW BULK NON
• 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: 17083603
• Report Number: 3006260740-2023-02339
• Device Sequence Number: 6243798
• Product Code: LJS
• UDI-Device Identifier: 00801741074820
• UDI-Public: (01)00801741074820
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/08/2023

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: SA5167436B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/30/2023; 06/26/2023; 08/08/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 06/23/2023; 07/13/2023; 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown