MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0603870

Device Problem Material Deformation (2976)

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

Event Date 01/05/2022

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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 11/2024).

Event Description

It was reported that prior to a port placement, the tip of the catheter allegedly had bent.The procedure was completed using another device.There was no patient contact.

Event Description

It was reported that prior to a port placement, the tip of the catheter allegedly bent.The procedure was completed using another device.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one bardport mri isp implantable port kit, one groshong catheter loaded with one cath-lock and a guidewire, two introducer needles, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one cath-lock lock, one syringe, one j-tip guidewire in a guidewire hoop, one 7.0fr introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is unconfirmed for the reported catheter tip bent issues as a no bends were noted to the groshong catheter.However, bunching was noted to the peel-apart sheath proximal to the sheath tip was considered to be the part of device usage on patient's body and it was not related to the original reported event.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.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: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13421585
• MDR Text Key: 285399184
• Report Number: 3006260740-2022-00135
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0603870
• Device Catalogue Number: 0603870
• Device Lot Number: REDZ2329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 73 KG