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

Model Number 1859660

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Difficult or Delayed Separation (4044)

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

Event Date 01/31/2023

Event Type  malfunction  

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.(expiration date: 05/2024).Device pending return.

Event Description

It was reported that during a port placement procedure, when peeling the sheath away, the plastic ring allegedly broke in two pieces and fell off of white plastic part of sheath making it difficult for radiologist.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 10.0f peel-apart sheath were returned for evaluation.Gross visual evaluation were performed.The investigation is confirmed for the reported difficulty in peeling the introducer sheath, loss or failure to bond issue and and identified deformation issue as twisting and deformation was noted throughout both sheath shafts and the plastic clear ring was noted to be broken.Also the sample was noted to be bent and one half of the peel-apart sheath shafts was noted to be missing the valve cap.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: d4 (expiration date: 05/2024).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.

Event Description

It was reported that during a port placement procedure, when peeling the sheath away, the plastic ring allegedly broke in two pieces and fell off of white plastic part of sheath making it difficult for radiologist.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure, when peeling the sheath away, the plastic ring allegedly broke in two pieces and fell off of white plastic part of sheath making it difficult for radiologist.It was further reported that the radiologist managed to finish the procedure by inserting the implanted vascular access device.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 10.0f peel-apart sheath were returned for evaluation.Gross visual evaluation were performed.The investigation is confirmed for the reported difficult separation, fracture, and material separation and the identified deformation issue as twisting and deformation was noted throughout both sheath shafts and the clear ring was broken away from the tab.Manufacturing site evaluation of the sample found that the top cap was detached in one of the halves of t-handle, the valve belonging to this half of the lid was absent in the sheath.Therefore, the cause of these conditions is related to the manufacturing/processing of the device.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: b5, d4 (expiration date: 05/2024).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 : 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: 16483339
• MDR Text Key: 310696211
• Report Number: 3006260740-2023-00680
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2023

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 Model Number: 1859660
• Device Catalogue Number: 1859660
• Device Lot Number: REGV0791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/04/2023
• Supplement Dates Manufacturer Received: 05/17/2023; 11/11/2023
• Supplement Dates FDA Received: 05/23/2023; 11/16/2023
• 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