MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN TITANIUM PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0606100
Medical Device Problem Codes	Disconnection (1171); Fracture (1260); Material Separation (1562); Connection Problem (2900); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The catalog number identified has not been cleared in the us but is similar to the titanium low-profile implantable port, broviac single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, broviac single-lumen, 6.6f products are identified.As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 03/2026).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.Device pending return.
Event or Problem Description
It was reported that forty eight days post port implantation procedure, the dislocation was allegedly found between the catheter and the chamber housing.It was further reported that the catheter was removed by using surgical operation.The procedure was completed using another device.The patient reported to be stable.
Event or Problem Description
It was reported that forty eight days post port implantation procedure, the dislocation was allegedly found between the catheter and the chamber housing.It was further reported that the catheter was removed by using surgical operation.The procedure was completed using another device.The patient reported to be stable.
Additional Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the titanium low-profile implantable port, broviac single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the titanium low-profile implantable port, broviac single-lumen, 6.6f products are identified in d2 and g4.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: one titanium implantable port attached to a catheter in two segments was returned for evaluation.Gross, microscopic visual and functional testing were performed.The investigation is unconfirmed for the reported catheter disconnection issue as fracture was identified during returned sample evaluation.The investigation is inconclusive for the reported migration issue as the exact circumstances at the time of the reported event are unknown and clinical conditions cannot be replicated to confirm these failures.The investigation is confirmed for the identified fracture and material separation issues as a complete circumferential break was noted on the attached catheter within the cath-lock.Under microscopic observation, the edges of the complete circumferential break on the proximal end of the distal catheter segment were noted to be jagged.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: 03/2026), g3.H11: h6 (device, method, result, conclusion).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.

• Brand Name: HICKMAN TITANIUM PORT SINGLE LUMEN
• 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: 15137416
• Report Number: 3006260740-2022-02991
• Device Sequence Number: 15284754
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0606100
• Device Catalogue Number: 0606100CE
• Device Lot Number: REFV2403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female