MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 TITANIUM LG SUB-Q-PORT K; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602230
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
Type of Reportable Event	Malfunction
Additional 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.(expiration date: 06/2025).
Event or Problem Description
It was reported that during a port placement procedure, the guidewire of the port allegedly had resistance and failure to advance.It was further reported that the guidewire was twisted.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during a port placement procedure, the guidewire of the port allegedly had resistance and failure to advance.It was further reported that the guidewire was twisted.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported guidewire stretched issue as the guidewire was noted to be raveled & uncoiled on the proximal end near to the guidewire tip.However, the investigation is inconclusive for the reported failure to advance and physical resistance issue as the exact circumstances at the time of the reported event was unknown and cannot be verified.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: d4 (expiration date: 06/2025).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 or Problem Description
It was reported that during a port placement procedure, the guidewire of the port allegedly had resistance.It was further reported that the guidewire was twisted.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The investigation is confirmed for the reported guidewire stretched ad identified core wire fracture issues as the guidewire was noted to be raveled & uncoiled on the proximal end near to the guidewire tip.Furthermore, upon zooming the provided photo, one of the core wire was appeared to be fractured.However, the investigation is inconclusive for the reported physical resistance issue as the exact circumstances at the time of the reported event was unknown and cannot be verified from the provided photo.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.D4 (expiration date: 06/2025).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: TITANIUM LG SUB-Q-PORT K
• Common Device Name: 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: 14726957
• Report Number: 3006260740-2022-02305
• Device Sequence Number: 20229598
• Product Code: LJT
• UDI-Device Identifier: 00801741025563
• UDI-Public: (01)00801741025563
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: 0602230
• Device Catalogue Number: 0602230
• Device Lot Number: REFQ0217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 07/30/2022; 12/07/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 08/03/2022; 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male