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

Catalog Number 0603870CE

Device Problem Fracture (1260)

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

Event Date 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is identified in common device name and pma/510k.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.Udi number (expiry date: 09/2026).

Event Description

It was reported that prior to port placement procedure, catheter allegedly fractured.There was no patient contact.

Event Description

It was reported that prior to port placement procedure, catheter allegedly fractured.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products is identified in d2 and g4.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 groshong catheter loaded with one cath-lock and a catheter stylet were returned for evaluation.Functional and gross visual evaluations were performed.The investigation is unconfirmed for the reported catheter fracture issue, as the port body was patent to infusion and aspiration without issue and no fracture was identified.Also, the split mentioned is the valve which will be present in the groshong port single lumen as per specifications.The definitive root cause could not be determined based upon 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 (expiry date: 09/2026), g3.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15830856
• MDR Text Key: 307321983
• Report Number: 3006260740-2022-05384
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603870CE
• Device Lot Number: REFZ3089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• 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