MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT,HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603880

Device Problems Fracture (1260); Difficult to Insert (1316); Dull, Blunt (2407)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, when tried to dilate the vein, the internal dilator was allegedly noted with a blunt tip.It was further reported that when tried to dilate, the tip of the internal dilator allegedly broke.Furthermore it was not possible to insert the device and there was bleeding.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: 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: 07/2026) h11: section a through f ¿ the information provided by bd represents all 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 pending return.

Event Description

It was reported that during a port placement procedure, when tried to dilate the vein, the internal dilator was allegedly noted with a blunt tip.It was further reported that when tried to dilate, the tip of the internal dilator allegedly broke.Furthermore, it was not possible to insert the device and there was bleeding.The procedure was completed using another device.There was no reported patient injury.

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 physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported dilator tip blunt, fracture and difficult to insert issues as no objective evidence was provided for review.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 (expiration date: 07/2026), g3, h6 (method).H11: b3, h6 (result, conclusion).H11: section a through f ¿ the information provided by bd represents all 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: M.R.I. LOW-PROFILE IMPLANTABLE PORT,HICKMAN SINGLE-LUMEN, 6.6F
• 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: 19086356
• MDR Text Key: 340693728
• Report Number: 3006260740-2024-01634
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025846
• UDI-Public: (01)00801741025846
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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: 0603880
• Device Lot Number: REGS1871
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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