MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1616070

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/30/2023

Event Type  Injury  

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: d4 (expiration date: 07/2024).H11: section a through f ¿ the information provided 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 : device pending return.

Event Description

It was reported that sometime post a port placement in the anterior thoracic region, after creating a subcutaneous pocket, the catheter was half covered against the stem, the catheter lock was advanced and when the catheter lock was attempted to be locked, it was difficult to engage and the catheter lock and catheter were allegedly detached from the stem.It was further reported that the catheter had allegedly entered the vessel but was removed.The current status of the patient is unknown.

Event Description

It was reported that sometime post a port placement in the anterior thoracic region, after creating a subcutaneous pocket, the catheter was half covered against the stem, the catheter lock was advanced and when the catheter lock was attempted to be locked, it was difficult to engage and the catheter lock and catheter were allegedly detached from the stem.It was further reported that the catheter had allegedly entered the vessel but was removed.The current status of the patient is unknown.

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 powerport clearvue slim implantable port, a detached cath-lock and a detached catheter in one segment were returned for evaluation.Functional, gross visual, tactile, dimensional and microscopic visual evaluations were performed.The cath-lock and the groshong catheter was noted to be separated from the port septum.Therefore the investigation is confirmed for the reported detachment issue.However, the investigation is inconclusive for the reported migration issue, as the exact circumstances at the time of the reported event are unknown.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 07/2024).H11: section a through f ¿ the information provided 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.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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: 18396798
• MDR Text Key: 331358125
• Report Number: 3006260740-2023-05867
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026461
• UDI-Public: (01)00801741026461
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122899
• 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: Physician
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1616070
• Device Lot Number: REHR1203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention