MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN/LEONARD CV CATHETER, DUAL/TRIPLE LUMEN CONNECTOR, RED; PORT AND CATHETER ACCESSORIES

Model Number	0601690
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device not returned.
Event or Problem Description
It was reported that sometime post port placement procedure, the red adapter leg allegedly broken at the same spot.It was further reported that the lumen was repaired for the third time with the repair kit.There was no reported patient injury.
Additional 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: b5, d4 (expiry date: 11/2024).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 : device pending return.
Event or Problem Description
It was reported that sometime post port placement procedure, the red adapter leg allegedly broken at the same spot.It was further reported that the leak allegedly occurred when flushing.Reportedly, the lumen was repaired for the third time with the repair kit.There was no reported patient injury.
Event or Problem Description
It was reported that sometime post port placement procedure, the red adapter leg allegedly broken at the same spot.It was further reported that the leak allegedly occurred when flushing.Reportedly, the lumen was repaired for the third time with the repair kit.There was no reported 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 s/l hickman catheter was returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter.However, striations were noted throughout the surface.The investigation is unconfirmed for the reported fracture and leak issues, as the catheter was patent to infusion and aspiration without issue.No leaks were observed.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: 11/2024).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.

• Brand Name: HICKMAN/LEONARD CV CATHETER, DUAL/TRIPLE LUMEN CONNECTOR, RED
• Common Device Name: PORT AND CATHETER ACCESSORIES
• 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: 15238764
• Report Number: 3006260740-2022-03193
• Device Sequence Number: 11958430
• Product Code: LJS
• UDI-Device Identifier: 00801741036422
• UDI-Public: (01)00801741036422
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2022

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: 0601690
• Device Catalogue Number: 0601690
• Device Lot Number: REFZ0176
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 08/24/2022; 11/10/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/20/2022; 11/15/2022
• 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
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 19 KG
• Patient Race: Asian