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	Difficult to Flush (1251); Fracture (1260); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified in 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.(expiry date: 12/2022).
Event or Problem Description
It was reported that during the port placement, the catheter allegedly pierced at the ring insertion level.There was no patient injury.
Event or Problem Description
It was reported that during the port placement, the catheter allegedly pierced at the ring insertion level.There was no patient injury.
Additional Manufacturer Narrative
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 ti powerport low profile attached to a catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported catheter puncture issue, as a partial compound break was noted on the catheter within the cath-lock.The edges of the partial compound break within the cath-lock 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: 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: d4 (expiry date: 12/2024).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 : see h10.
Event or Problem Description
It was reported that during the port placement, the catheter allegedly pierced at the ring insertion level.It was further reported that the catheter allegedly difficult to be flushed.There was no 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: one ti powerport low profile attached to a catheter was returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.In addition to the physical sample received for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported catheter fracture as a partial compound break was noted on the catheter within the cath-lock.The edges of the partial compound break within the cath-lock were noted to be jagged.However, the investigation is inconclusive for the reported difficult to flush issue as the exact circumstances at the time of the reported event are unknown.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: 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.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 : 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12370639
• Report Number: 3006260740-2021-03513
• Device Sequence Number: 19818073
• 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
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2022

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: 0606100
• Device Catalogue Number: 0606100CE
• Device Lot Number: REET2749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 02/04/2022
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/15/2021; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2020
• 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: Unknown