MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806061

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)

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

Event Date 11/24/2020

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 return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).

Event Description

It was reported that prior to the procedure, the sterile barrier of the package allegedly broken.There was no patient contact.

Manufacturer Narrative

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 powerport isp kit was returned for evaluation and three electronic photos were provided for review.Visual evaluation was performed.The investigation is confirmed for the reported hole in the device package and delivered as unsterile product issues as the tunneler inside the package was found penetrating the inner and outer plastic tray of the package.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 (expiry date: 01/2022).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.

Event Description

It was reported that prior to the procedure, the sterile barrier of the package allegedly broken.There was no patient contact.

Event Description

It was reported that prior to the procedure, the tip of the catheter was allegedly outside the package.There was no patient contact.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the mri powerport isp products that are cleared in the us.The pro code and 510 k number for the mri powerport isp products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.A device history record review is not required.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: one mri powerport isp kit was returned for evaluation and three electronic photos were provided for review.Visual evaluation was performed.The investigation is confirmed for the reported hole in the device package and delivered as unsterile product issues as the tunneler inside the package was found penetrating the inner and outer plastic tray of the package.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 (expiry date: 01/2022).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.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the mri powerport isp products that are cleared in the us.The pro code and 510 k number for the mri powerport isp products are identified in d2 and g4.H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.A device history record review is not required.However, the device history records were reviewed and there was nothing found to indicate there was a manufacturing related cause for these reports.Investigation summary: one mri powerport isp kit was returned for evaluation and three electronic photos were provided for review.Visual evaluation was performed.The investigation is confirmed for the reported hole in the device package and delivered as unsterile product issues as the tunneler inside the package was found penetrating the inner and outer plastic tray of the package.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 (expiry date: 01/2022), g3 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.See h10.

Event Description

It was reported that prior to the procedure, the tip of the catheter was allegedly outside the package.There was no patient contact.

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• 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: 11044552
• MDR Text Key: 222691061
• Report Number: 3006260740-2020-21002
• Device Sequence Number: 1
• Product Code: LJT
• 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,Followup,Followup
• Report Date: 08/19/2021

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: 8806061
• Device Lot Number: REEP4337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 06/17/2021; 07/19/2021; 08/19/2021
• Supplement Dates FDA Received: 06/23/2021; 07/21/2021; 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other