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

Catalog Number 1806060J

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2022

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, the rubber of the syringe was allegedly detached when negative pressure was applied.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified.As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.

Event Description

It was reported that during a port placement procedure, the rubber of the syringe was allegedly detached when negative pressure was applied.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one monoject syringe was returned for evaluation.Gross visual evaluation was performed.The investigation is confirmed for the reported the rubber of the syringe was detached as rubber seal inside the syringe was noted to be partially detached from the plunger.A definitive root cause could not be determined based upon the provided 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.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 ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 16191700
• MDR Text Key: 307569255
• Report Number: 3006260740-2022-06082
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111624
• UDI-Public: (01)00801741111624
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• 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,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1806060J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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