MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1859660

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Difficult to Insert (1316); Material Separation (1562)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

It was reported that during a port placement procedure, one half of the plastic ring of the sheath allegedly broke off.It was reported that it was allegedly difficult to insert into the sheath and vein.Reportedly, the catheter was able to get into the vein and the procedure was completed.There was no reported patient injury.

Manufacturer Narrative

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.D4 (expiry date: 07/2024).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.

Event Description

It was reported that during a port placement procedure, one half of the plastic ring of the sheath allegedly broke off of the sheath.It was further reported that it was allegedly difficult to insert the catheter into the sheath and vein.Reportedly, the catheter was able to be get into the vein and the procedure was completed.There was no reported patient injury.

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 fully peeled 10.0fr peel-apart sheath was returned for evaluation.Gross visual, microscopic and functional evaluations were performed.One valve cap was received detached from the t-handle.The other half of the valve cap was fully attached to the t-handle.Therefore, the investigation has been confirmed for identified material separation and loss of bond issues.The investigation is unconfirmed for fracture issue as the more appropriate failure material separation has been confirmed.Also, the investigation remains inconclusive for the reported difficult to insert as the exact circumstances could not be reproduced and the catheter was not returned.The definitive root cause was determined to be manufacturing related issue.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: b5, d4 (expiry date: 07/2024), g3, h6 (device).H11: h6 (method, result, conclusion).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: POWERPORT ISP M.R.I. IMPLANTABLE PORT, SILICONE SINGLE-LUMEN, 9.6F
• 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: 17539076
• MDR Text Key: 321285946
• Report Number: 3006260740-2023-03502
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027222
• UDI-Public: (01)00801741027222
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K073423
• 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: 01/03/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1859660
• Device Lot Number: REGY2315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 01/04/2024
• 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