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

Catalog Number 8808561

Device Problems Illegible Information (4050); Missing Information (4053)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 08/2022).

Event Description

It was reported that during preparation of a port placement procedure, the device allegedly had no markings on catheter.The procedure was completed using another device.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.However, the device history record review was performed and the lot met all release criteria.Investigation summary: the sample was not returned for evaluation; however, one electronic photo was provided for review.The photo shows only a partial view of the catheter and it is unknown whether there are depth marking on the catheter.Therefore.The investigation is inconclusive for the reported missing information.Based upon the available information, the definitive root cause for this event is unknown.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: d4 (expiry date: 08/2022), g3, h6 (method) h11: h6 (device, result, 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.

Event Description

It was reported that during preparation of a port placement procedure, the device allegedly had no markings on catheter.The procedure was completed using another device.There was no patient contact.

• Brand Name: POWERPORT MRI ISP, 8 FR GROSHONG, INT WO SP, 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: 11777907
• MDR Text Key: 251664491
• Report Number: 3006260740-2021-01668
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8808561
• Device Lot Number: REEW2274
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other