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 Fracture (1260); Suction Problem (2170)

Patient Problem Air Embolism (1697)

Event Date 02/10/2021

Event Type  Injury  

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.The investigation of the reported event is currently underway.(expiry date: 04/2023).Device pending return.

Event Description

It was reported that during port implant, the device allegedly had an air contamination and blood return could not be confirmed.It was further reported that another device was used to complete the procedure.The patient's current status was unknown.

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 powerport mri isp, one groshong catheter with pre-inserted stylet, one flushing connector, one introducer needle, one straight non-coring needle, two catheter locks, 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.Visual, microscopic visual and functional evaluation were performed on the returned device.The investigation is confirmed for the identified fracture problem as multiple cracks were noted on the introducer needle hub.Aspiration difficulty was noted upon aspirating the needle during functional evaluation.No leaks were noted from the needle hub, although the device did not fully aspirate and it appeared that the in-house syringe was aspirating water as well as air.However, the investigation is inconclusive for the reported aspiration difficulty and air leak issue as the exact circumstances at the time of the reported event are unknown and the sample evaluation results indicating difficulty under laboratory conditions are not by themselves sufficient to confirm this event occurred under clinical conditions.A definitive root cause could not be determined based upon the 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.Expiry date: 04/2023.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.

Event Description

It was reported that during port implant, the device allegedly had an air contamination and blood return could not be confirmed.It was further reported that another device was used to complete the procedure.The patient's current status was 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: 11434488
• MDR Text Key: 238321437
• Report Number: 3006260740-2021-00729
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• 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: REEU1246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention