MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602840
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the m.R.I.Implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510k number for the m.R.I.Implantable port, groshong single-lumen, 8f is identified.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.(expiry date: 07/2024).
Event or Problem Description
It was reported that prior to a port placement, the device allegedly broke.The procedure was completed using another device.There was no patient contact.
Additional 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.Implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510k number for the m.R.I.Implantable port, groshong single-lumen, 8f 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 m.R.I.Implantable port was returned for evaluation.Gross visual and microscopic evaluations were performed on the returned device.The investigation is confirmed for the reported fracture and identified material separation issue as complete circumferential break was observed to the port stem approximately 4mm from the port body.The edges of the circumferential break appeared jagged and non-uniform in shape.Furthermore, a manufacturing review was conducted and the damage showed in the pictures cannot be concluded as manufacturing process related.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: 07/2024), g3, h6 (device).H11: section a through f: the information provide 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.
Event or Problem Description
It was reported that prior to a port placement, the device allegedly broke.The procedure was completed using another device.There was no patient contact.
Additional 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.Implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510k number for the m.R.I.Implantable port, groshong single-lumen, 8f 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 m.R.I.Implantable port was returned for evaluation.Gross visual and microscopic evaluations were performed on the returned device.The investigation is confirmed for the reported fracture as circumferential break was observed to the port stem approximately 4mm from the port body.The edges of the circumferential break appeared jagged and non-uniform in shape.Furthermore, a manufacturing review was conducted and the damage showed in the pictures cannot be concluded as manufacturing process related.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 (expiry date: 07/2024).H11: section a through f: the information provide 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 : see h10.
Event or Problem Description
It was reported that prior to a port placement, the device allegedly broke.The procedure was completed using another device.There was no patient contact.

• Brand Name: M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11918332
• Report Number: 3006260740-2021-02103
• Device Sequence Number: 3197265
• Product Code: LJT
• UDI-Device Identifier: 00801741025730
• UDI-Public: (01)00801741025730
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2021

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: 0602840
• Device Catalogue Number: 0602840CE
• Device Lot Number: REDV1388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 09/30/2021; 12/29/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 10/04/2021; 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown