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

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regs3161 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer that the microintroducer sheath failed to insert passed the skin and folded back or began to split upon attempt to insert into the vein.No other information was provided.

Event Description

It was reported by the customer that the microintroducer sheath failed to insert passed the skin and folded back or began to split upon attempt to insert into the vein.No other information was provided.

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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of the microintroducer failing to insert passed the skin is confirmed and was determined to be due to insertion techniques.One 3.5 fr microintroducer was returned for evaluation.An initial visual observation showed blood use residues throughout the returned device and visual damage to the distal end of the gray microintroducer sheath.No obvious bends were noted along the microintroducer.A microscopic observation revealed deformation to the distal end of the gray sheath of the microintroducer, and a gradual taper was visible from manufacturing.The complaint of difficulty inserting a microintroducer is confirmed.Possible causes may include insertion procedure of the device or insertion angles of the device, as it may catch on the patient¿s skin or vessel walls.

• Brand Name: DOT 3FR SL PROV ML
• Type of Device: 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16071016
• MDR Text Key: 308159734
• Report Number: 3006260740-2022-05904
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REGS3161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other