MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 3F SL MAX 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that in the kits, the rubber stopper holding the wire in place inside the catheter does not fully seal.During insertion, when the picc containing the wire is checked for blood return, air enters the clear plastic extension piece, putting the patient at risk for air embolism, and if flushed then fluid leaks out where the wire goes in.Additional information received 21 august 2023: the event did directly involve a patient and a user.Event did not effect the patient.The event did not involve an urgent or life threatening medical situation.No harm came to the patient, and they did not require any treatment as a result of the event.The event did not lead to any delay in patient care.The problem was that the picc could not be flushed with the guidewire present once blood return had been checked, since withdrawing blood also drew air into the extension tubing.Once air was in the extension tubing, the line could not be flushed until the wire was removed.If the line had been flushed with air, the patient would have sustained an air embolism.Without being able to flush the line prior to wire removal, the line could have clotted off during placement of the picc, and the line would have had to be replaced.This did not happen because the line was in place and the tip positioning check was already completed.So, to avoid harm, once air was noted to be in the extension tubing, the wire and extension catheter were removed, the picc was flushed, and the procedure was completed normally.
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.
Event or Problem Description
It was reported by the customer that in the kits, the rubber stopper holding the wire in place inside the catheter does not fully seal.During insertion, when the picc containing the wire is checked for blood return, air enters the clear plastic extension piece, putting the patient at risk for air embolism, and if flushed then fluid leaks out where the wire goes in.Additional information received 21 august 2023: the event did directly involve a patient and a user.Event did not effect the patient.The event did not involve an urgent or life threatening medical situation.No harm came to the patient, and they did not require any treatment as a result of the event.The event did not lead to any delay in patient care.The problem was that the picc could not be flushed with the guidewire present once blood return had been checked, since withdrawing blood also drew air into the extension tubing.Once air was in the extension tubing, the line could not be flushed until the wire was removed.If the line had been flushed with air, the patient would have sustained an air embolism.Without being able to flush the line prior to wire removal, the line could have clotted off during placement of the picc, and the line would have had to be replaced.This did not happen because the line was in place and the tip positioning check was already completed.So, to avoid harm, once air was noted to be in the extension tubing, the wire and extension catheter were removed, the picc was flushed, and the procedure was completed normally.It was reported this occurred with three devices.This report addresses the first device.
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 the customer that in the kits, the rubber stopper holding the wire in place inside the catheter does not fully seal.During insertion, when the picc containing the wire is checked for blood return, air enters the clear plastic extension piece, putting the patient at risk for air embolism, and if flushed then fluid leaks out where the wire goes in.Additional information received 21 august 2023: the event did directly involve a patient and a user.Event did not effect the patient.The event did not involve an urgent or life threatening medical situation.No harm came to the patient, and they did not require any treatment as a result of the event.The event did not lead to any delay in patient care.The problem was that the picc could not be flushed with the guidewire present once blood return had been checked, since withdrawing blood also drew air into the extension tubing.Once air was in the extension tubing, the line could not be flushed until the wire was removed.If the line had been flushed with air, the patient would have sustained an air embolism.Without being able to flush the line prior to wire removal, the line could have clotted off during placement of the picc, and the line would have had to be replaced.This did not happen because the line was in place and the tip positioning check was already completed.So, to avoid harm, once air was noted to be in the extension tubing, the wire and extension catheter were removed, the picc was flushed, and the procedure was completed normally.It was reported this occurred with three devices, but only one sample was returned for investigation.This report addresses that sample.
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 leak in the hub was confirmed.The returned sample was found to exhibit the same features as a known issue h3 other text : evaluation findings are in section h.11.

• Brand Name: DOT PROV 3F SL MAX 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: 17642867
• Report Number: 3006260740-2023-03743
• Device Sequence Number: 17540583
• Product Code: LJS
• UDI-Device Identifier: 00801741130342
• UDI-Public: (01)00801741130342
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1173108D
• Device Lot Number: REHP0179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/17/2023; 10/18/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/29/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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 Sex: Unknown