MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD PICC CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Deformation (2976)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of refy3896 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after skin expanding in picc puncture, when inserting the distal end of guide wire into introducer sheath, the insertion failed since the distal end of guide wire was not smooth and there was a protrusion.Multiple attempts were made, but all failed.A new picc catheter was opened and the guide wire inside was used and successfully inserted into the sheath.A comparison of the two guide wires was made and, "the initial guide wire was evidently uneven at the distal end as compared with the normal one.".

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 threading the microintroducer over the guidewire due to a rough wire was confirmed but the cause is unknown.A single photograph of the proximal ends of two guidewires was returned for evaluation.One of the guidewires appeared unremarkable to gross visual observation.Per the event description, this guidewire was photographed for comparison purposes.The other guidewire was circled in the photograph.The proximal end of this guidewire appeared rough and irregular; the wire near the proximal end appeared to have a slightly larger outer diameter in a couple of areas compared to the rest of the wire.The photo quality did not allow for a clear view of the coils on the guidewire; however, the irregular profile of the proximal end of the wire was likely caused by the coils on the coil wire being displaced.The increase in the effective outer diameter of the wire would have contributed to the reported difficult passage of the microintroducer.Although the damage to the wire could be confirmed, the exact root cause of the damage could not be determined from the returned photograph.A review of the manufacturing records could not be conducted as the product kit implicated by the complainant did not contain a guidewire within the package.Potential contributing factors could include attempted insertion of the wire against resistance or manipulation of the wire causing displacement of the coils.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that after skin expanding in picc puncture, when inserting the distal end of guide wire into introducer sheath, the insertion failed since the distal end of guide wire was not smooth and there was a protrusion.Multiple attempts were made, but all failed.A new picc catheter was opened and the guide wire inside was used and successfully inserted into the sheath.A comparison of the two guide wires was made and, "the initial guide wire was evidently uneven at the distal end as compared with the normal one.".

• Brand Name: BARD PICC CATHETER
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16300910
• MDR Text Key: 308831397
• Report Number: 3006260740-2023-00351
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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