MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8808560

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2022).

Event Description

It was reported that prior to a procedure, the instruction manual allegedly seemed to have a typo error.There was no patient contact.

Event Description

It was reported that prior to a procedure, the instruction manual allegedly seemed to have a typo error.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this lot number and the lot met all release criteria.A device history record review is not required.Investigation summary: the sample was not returned for evaluation, two electronic photos were provided for review.The photos shows patient kit and instructions for use of the device, which indicates "spatial gradient field of 330 gauss/cm or less".Upon reviewing the instructions for use of the device, the provided spatial gradient field value seems to be correct.No other anomalies/ discrepancies were noted on the provided instructions for use.However the investigation is inconclusive for reported mislabeled instruction issue as instructions for use that reference a lower spatial gradient of 330 guass/cm are not technically incorrect, as 3000 gauss/cm is also well below what internal testing substantiates at 12,400 guass/cm.However, m282-020 and m282-021 recommend 3000 for all ports based on "clinically-relevant wording in the instructions for use, a value of 3000 guass/cm is recommended." all bard ports have testing to support mr conditional up to 3000 gauss/cm, even ports in which the labeling (instructions for use, patient guide, etc.) state a lower number.Therefore, it is reasonable to suggest that conducting an mri procedure above 330 and below 3000 would align with a negligible severity of harm.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Instructions for use states: non-clinical testing has demonstrated the device is mr conditional.It can be safely scanned under: static magnetic field of 3 tesla or less.Spatial gradient field of 330 gauss/cm or less.Maximum specific absorption rate (sar) of 4 w/kg for 30 minutes of scanning.H10: d4 (expiry date: 06/2022), g3, h6 (method).H11: h6 (result and conclusion).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.H3 other text : device not returned.

• Brand Name: POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11249379
• MDR Text Key: 229331791
• Report Number: 3006260740-2021-00119
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808560
• Device Lot Number: REEU0762
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other