MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870C

Device Problems Suction Problem (2170); Obstruction of Flow (2423); Scratched Material (3020)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products are identified in common device name, procode and pma/510(k).(expiry date: 11/2022).

Event Description

It was reported that during a port placement procedure through right jugular vein, in right chest wall, the device allegedly unable to aspirate.It was further reported that catheter was obstructed during the operation.The procedure was completed using another device.There was no reported patient injury.

Event Description

It was reported that during a port placement procedure through right jugular vein, the device allegedly unable to aspirate.It was further reported that catheter was obstructed during the operation.The procedure was completed using another device.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 m.R.I.Low-profile implantable port, groshong single-lumen, 7f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f products are identified in d2 and g5.H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one mri low profile port attached to a groshong catheter with cath-lock, one flushing connector, one introducer needle, one straight non-coring needle, one vein pick, one catheter lock, one syringe, one guidewire in a guidewire hoop, one introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.One electronic photo was also provided for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The port body and attached catheter were patent to infusion and aspiration without issue.The investigation is inconclusive for the reported inability to aspirate and obstruction of flow issues, as the exact circumstances at the time of the reported event are unknown and the reported event could not be reproduced in the lab.The investigation is confirmed for the identified scoring issue, as scoring was noted on the cath-lock.The 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 provide 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: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• 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: 11075140
• MDR Text Key: 223775216
• Report Number: 3006260740-2020-21113
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• 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: 01/11/2021

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: 0603870C
• Device Lot Number: REDZ0872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 63