MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0606150

Device Problems Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Failure to Advance (2524)

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

Event Date 12/22/2023

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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2027).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.

Event Description

It was reported that reported that during a port placement procedure, the guidewire allegedly failed to advance.It was further reported that the guidewire was allegedly difficult to remove thus removed along with the needle due to the stretching of the guidewire.The procedure was completed using another device.There was no reported patient injury.

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 bent tunneler, one straight non-coring needle, one right angle non-coring needle ,one catheter stylet, one vessel dilator, two introducer needles and one j-tip guidewire loaded into a guidewire hoop were returned for evaluation.Gross visual and microscopic visual evaluations were performed.Multiple bends and uncoiling were noted throughout the j-tip guidewire.The distal portion of the j-tip guidewire appeared stretched.The flat core wire was noted to have a complete break on the distal end.Both core wires were not exposed on the uncoiled portion of the guidewire.Therefore, the investigation is confirmed for the reported stretched and identified fracture and material separation issue.However, the investigation is inconclusive for the reported difficult to remove and failure to advance issues, as the exact circumstances at the time of the reported event was unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 12/2027), g3, h6 (device).H11: b3, h6 (method, 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.

Event Description

It was reported that during a port placement procedure, the guidewire allegedly failed to advance.It was further reported that the guidewire was allegedly difficult to remove thus removed along with the needle due to the stretching of the guidewire.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18620880
• MDR Text Key: 335407682
• Report Number: 3006260740-2024-00277
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026058
• UDI-Public: (01)00801741026058
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K050310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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 Catalogue Number: 0606150
• Device Lot Number: REHQ1587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 03/29/2024
• 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