MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 1806060J

Device Problems Fracture (1260); Device Damaged Prior to Use (2284); Material Deformation (2976)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 05/2022).

Event Description

It was reported that prior to port placement, the tip of the flush connecter was allegedly crushed and was not opened.There was no patient contact.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport mri isp, one catheter, one flushing connector, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, one vein pick, one catheter lock, one guidewire in a guidewire hoop, one introducer peel-apart sheath and vessel dilator, one safety infusion set, and one tunneler were returned.The investigation is confirmed for the reported device damage prior to use as the distal tip of the flushing connector was noted to be compressed together in a flat manner and appeared completely sealed off.Furthermore, the material on the end appeared deformed and heat sealed.The measurements of the flushing connector recorded during sample evaluation were slightly out of specification but not considered definitely out of tolerance as manufactured as the procedure/use factors could have contributed to a tiny increase/decrease in the dimension of the flushing connector.Per the reynosa evaluation, this condition was caused during the manufacturing process, and the cause of the tip of the flush connecter was allegedly crushed was determined to be manufacturing related.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: 05/2022).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.H3 other text : see h10.

Event Description

It was reported that prior to port placement, the tip of the flush connecter was allegedly crushed and was not opened.There was no patient contact.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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
• MDR Report Key: 11841890
• MDR Text Key: 251194082
• Report Number: 3006260740-2021-01888
• 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
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1806060J
• Device Lot Number: REEV2603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other