MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MRI POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK MRI POWER PORT

Device Problems Fracture (1260); Scratched Material (3020)

Patient Problems Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record will not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that post port placement, the port catheter allegedly fractured.It was further reported that the patient experienced swelling.The patient current status is unknown.

Event Description

It was reported that sometime post port placement, the port catheter allegedly fractured.There was no patient injury.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one mri powerport attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The investigation is confirmed for the reported port fracture issue and the identified scratched material issue, as a damage was observed on one of the suture holes on the port body and a scoring mark was noted on the cath-lock.A definitive root cause could not be determined based on the 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.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 : see h10.

Event Description

It was reported that sometime post port placement, the port catheter allegedly fractured.It was further reported that the patient experienced swelling.The patient current status is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review, a device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one mri powerport attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.A damage was observed on one of the suture holes on the port body and a scoring mark was noted on the cath-lock.However, the findings are incidental and not related to the reported event.The investigation is unconfirmed for the reported catheter fracture issue, as no damage were observed on the catheter.The port body with attached catheter segment was patent to infusion and aspiration without issue.No leaks were observed.A definitive root cause could not be determined based upon the 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.H10: g3, h6 (method).H11: b5, h1, h6 (patient, 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.

• Brand Name: MRI POWER PORT
• 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: 10807498
• MDR Text Key: 215273552
• Report Number: 3006260740-2020-20431
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK MRI POWER PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 05/18/2021; 07/12/2021
• Supplement Dates FDA Received: 05/28/2021; 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other