MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PPICC 5F,D/L, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 02/03/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reft2024 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that picc insertion using 3cg confirmed tip position at caj.On cx-ray tip in mid svc.Experienced vat inserted l) sided picc.Peaked p wave and neg deflection seen.C x-ray shows tip in mid svc.Picc currently remains insitu and being used.Erroneous results: yes; tip of catheter was at mid svc rather that caj as suggested by 3cg.Safety issue: yes; may impact patient if tip not placed in optimal position.

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reft2024 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that picc insertion using 3cg confirmed tip position at caj.On cx-ray tip in mid svc.Experienced vat inserted l) sided picc.Peaked p wave and neg deflection seen.C x-ray shows tip in mid svc.Picc currently remains insitu and being used.Erroneous results: yes; tip of catheter was at mid svc rather that caj as suggested by 3cg.Safety issue: yes; may impact patient if tip not placed in optimal position.

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, image analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of misalignment between the ecg and the radiographic images, with regards to catheter tip location, were inconclusive due to the sample condition.Two radiographic images and an ecg printout were provided for evaluation of this complaint.The intravascular ecg waveform showed a p-wave that was present, identifiable, and fairly consistent while the external waveform was not consistent.The p-wave appeared to elevate in the printout.However, only the user would be able to tell if they inserted the picc tip deep enough to see the p-wave maximize and then start to diminish or display an initial negative deflection.The second and third ecg complex, moving from left to right, appeared to have minor deflections.However, the deflections appeared to be part of the general noise as opposed to a true negative deflection caused by entering the right atrium, which would appear more consistent and prominent.The first radiographic image that was received with the ecg printout and occurred during the incident showed a left placed catheter terminating in the mid svc rather than the caj.The second radiographic image was reportedly of the same patient at a later date (feb.09, 2022).In this image the left sided catheter appeared to have the tip overlaying the right atrium.The second radiographic image appeared to be from an unusual angle and was taken during expiration.As an ecg printout is a snapshot in time performed by the placing physician, it is not possible to independently conclude if it definitively suggests the catheter position in the caj.Possible contributing factors for an ecg printout indicating the catheter tip being in the correct location prior to it actually being in the correct location could include patient physiology (e.G., heart rhythm anomalies or cardiac rhythm devices), the 3cg tcs not properly reading the stylet/ecg (e.G., noise on the signal), or clinical procedure (e.G., left-sided placements can cause a premature p-wave increase).Possible contributing factors for actual or perceived changes in catheter tip location in the radiographic images could include imaging technique (e.G., projection, patient position, and respiratory pattern), patient movements, or catheter securement method.As the complaint could not be independently confirmed, it will be recorded as inconclusive.However, the complaint has been documented and will continue to be monitored as part of ongoing complaint trending.

Event Description

It was reported that picc insertion using 3cg confirmed tip position at caj.On cx-ray tip in mid svc.Experienced vat inserted l) sided picc.Peaked p wave and neg deflection seen.C x-ray shows tip in mid svc.Picc currently remains insitu and being used.Erroneous results: yes; tip of catheter was at mid svc rather that caj as suggested by 3cg.Safety issue: yes; may impact patient if tip not placed in optimal position.

• Brand Name: PPICC 5F,D/L, 3CG
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13596076
• MDR Text Key: 286119283
• Report Number: 3006260740-2022-00449
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 22285118
• Device Lot Number: REFT2024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 04/22/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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