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	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of regt4077 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported by the customer "per vat team member "two 3fs picc introducers are long and flimsy.One has a white ridge and the inserter was not able to get it through the patient's skin.The second one got a burr on the end trying to insert in the patient's skin and a few notches in the outside channel." this report addresses the inserter with the burr at the end.
Event or Problem Description
It was reported by the customer "per vat team member "two 3fs picc introducers are long and flimsy.One has a white ridge and the inserter was not able to get it through the patient's skin.The second one got a burr on the end trying to insert in the patient's skin and a few notches in the outside channel." this report addresses the inserter with the burr at the end.
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 following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult insertion of the microintroducers was inconclusive due to the sample condition.A photograph of the two implicated 3.5fr ptfe microintroducers was returned for evaluation.Both samples were found within plastic bags.One of the samples consisted of the dilator within the sheath while the other sample was the sheath without the inlaid dilator.The sheath had not been and peeled on either sample.The distal end of the dilator and sheaths could not be clearly visualized in the returned photograph.No close-up photographs were provided of the reported ridges or burrs seen on the devices.The submitted photograph did not contain distinguishing features that could aid in confirmation of the complaint nor identification of a specific root cause.Therefore, this complaint will be recorded as inconclusive at this time.Possible contributing factors could include too small of an incision, a steep insertion angle, a poor transition of the introducer sheath to the dilator, or damage to the dilator or sheath prior to use.Sheath damage can be minimized by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16039723
• Report Number: 3006260740-2022-05828
• Device Sequence Number: 20143014
• Product Code: LJS
• UDI-Device Identifier: 00801741130342
• UDI-Public: (01)00801741130342
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S1173108D
• Device Lot Number: REGT4077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 Sex: Unknown