MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 9808560

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Deformation Due to Compressive Stress (2889); Scratched Material (3020)

Patient Problems Erythema (1840); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/31/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The device has been returned to the manufacturer for evaluation.However, an image is provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that nearly two years post port placement, patient allegedly experienced redness near the subcutaneous tunnel.It was further reported that leakage of anti-cancer agent was noted.Reportedly, kinks were noted at two sites.The current status of patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review, device history record review and complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: one powerport mri isp attached to a groshong catheter was returned for evaluation and two medical images were provided for review.The investigation is confirmed for cath-lock damage, scoring, fracture, leakage and kink issue as a split was noted on the catheter between the cath-lock and port body.Scoring and tool damage were identified on the cath-lock.The cath-lock was also observed to be not seated against the port body and a portion of the port stem was exposed.A circumferential split was noted just distal to the cath-lock and also a kink was noted to the catheter.Similarly, the edges of the split just distal to the cath-lock appeared to have penetrated to the inner catheter.Upon infusion of the port body with attached catheter segment, leaks were observed from the split just distal to the cath-lock and from the circumferential split from the distal end of the cath-lock.A definitive root cause could not be determined.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 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.

Event Description

It was reported that nearly two years post port placement, patient allegedly experienced redness near the subcutaneous tunnel.It was further reported that leakage of anti-cancer agent was noted.Reportedly, kinks were noted at two sites.The current status of patient status is unknown.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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
• MDR Report Key: 10859308
• MDR Text Key: 216831848
• Report Number: 3006260740-2020-20559
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 75