MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603870C

Device Problems Fracture (1260); Suction Problem (2170); Scratched Material (3020)

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

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

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 was returned for evaluation.One electronic photo was also provided for review.Gross visual, microscopic and functional testing were performed.Based on the sample evaluation, the investigation is confirmed for unable to aspirate, cath-lock damage and fracture as tool damage and scoring were identified on the cath-lock.A circumferential split was noted from the distal end of the cath-lock.The port body and attached catheter were patent to infusion and aspiration with a leak noted at the circumferential split.Also, aspiration of water into the syringe was attempted but was unsuccessful, air was aspirated into the syringe.Based upon the available information 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.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.(expiry date: 05/2022).

Event Description

It was reported that one day post port placement procedure through right jugular vein in right chest wall, the device was allegedly unable to aspirate.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: GROSHONG PORT SINGLE LUMEN
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11264725
• MDR Text Key: 230752053
• Report Number: 3006260740-2021-00177
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• 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: REDT3040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 49