MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, SUBCLAVIAN

Model Number N/A

Device Problem Material Frayed (1262)

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

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

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 will evaluate.Results are expected soon.A lot history review (lhr) of reez2098 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the wire was stripping.It was stated the patient is fine.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.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 an elongated guidewire was confirmed but the cause is unknown.A photograph of a damaged guidewire was returned for evaluation.A complete break was seen in the guidewire and the outer coil wire was elongated both proximal and distal of the break.Elongation of the coil wire can occur when the inner core wire is either broken or sheared.The exact root cause of the damage could not be determined from the photograph alone.Microscopic examination and dimensional analysis could not be conducted without the physical sample.Possible contributing factors could include the insertion technique, dimensional incompatibility between interfacing devices, or the guidewire being retracted through the needle.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stick within the needle.If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.

Event Description

It was reported that the wire was stripping.It was stated the patient is fine.No other information was provided.

• Brand Name: FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• Type of Device: CATHETER, SUBCLAVIAN
• 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: 15159956
• MDR Text Key: 304906377
• Report Number: 3006260740-2022-03029
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K881743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• 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: 5678200
• Device Lot Number: REEZ2098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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