MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PROV 4F DL IR 70CM NI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 his facility places the 4fr dl powerpicc provena.Caller states he is looking to place the 3fr powerpicc provena or sv because they have experienced a recent increase in patients experiencing deep vein thrombosis.Caller describes increasing use of the brachial vein as it is a larger vein when placing piccs.Caller states that a 3fr may help with this issue.Caller asking about the powerplcc sv with sherlock and powerpicc kits ending in the letter "p".Ms&s discussed the differences in powerpicc provena vs sv (internal diameter, flow rates, etc).Discussed kit contents for kits ending in "p".Suggested he speak to his sales rep in the area to assess which products would work best for their patient population.Emailed brochures for provena and sv.Provided sales rep contact information.The customer reported an "increase in deep vein thrombosis in patients" however the exact number of events was not provided.Additional information received 10/12/2023: the vein was appropriately chosen, no change in technique, no external compression.Event did not involve an urgent/life threatening medical situation.It was stated no defect was noted in the product.Additional information 10/24/2023: it was reported that this occurred three times over the last 6 months.The piccs were inserted anywhere from a couple of weeks to a month.These were found when the referring providers office sent patients for us.The clots were treated with anticoagulation.To the best of the provider's knowledge the patients recovered.This report addresses the third event.

• Brand Name: PROV 4F DL IR 70CM NI
• 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: 18112134
• Report Number: 3006260740-2023-05115
• Device Sequence Number: 7670891
• Product Code: LJS
• UDI-Device Identifier: 00801741130052
• UDI-Public: (01)00801741130052
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: S3274355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown