MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; MIDLINE CATHETER

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	10/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of regp1017 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "that the introducer sheath would not advance pass the skin despite many attempts.The sheath does display splitting at the transition point from the white stylet to the gray sheath." additional information received: a new, larger introducer sheath was used to complete the procedure.No new vessel access needed.Customer reported more bleeding than usual due to vessel trauma from using a larger introducer needle.There was no delay in medication and no negative outcome to the patient.
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 difficulty inserting the introducer was confirmed but the cause is unknown.A single photograph of a 3.5fr microintroducer/dilator/sheath was returned for evaluation.The dilator was inlaid within the sheath and the sheath handles had not been split.It was reported that splits were seen at the transition between the dilator and sheath.No tears or splits were evident in the sheath material in the photograph.However, it is possible that the damage had occurred on the side of the sheath that was not visible in the photograph.The sheath material did appear to be slightly flared away from the dilator shaft and the dilator shaft was slightly bowed.These characteristics are indicative of difficulty inserting the introducer.However, the root cause of the difficult insertion could not be determined.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 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.
Event or Problem Description
It was reported by the customer "that the introducer sheath would not advance pass the skin despite many attempts.The sheath does display splitting at the transition point from the white stylet to the gray sheath." additional information received: a new, larger introducer sheath was used to complete the procedure.No new vessel access needed.Customer reported more bleeding than usual due to vessel trauma from using a larger introducer needle.There was no delay in medication and no negative outcome to the patient.

• Brand Name: DOT 3FR SL PROV ML
• Common Device Name: MIDLINE CATHETER
• 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: 15821480
• Report Number: 3006260740-2022-05349
• Device Sequence Number: 6109026
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REGP1017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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