MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1716070
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that prior to insertion the physician noticed a 2-3 cm silver strip in the catheter.A new device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one ti lp powerport slim with 6 fr s/l polyurethane catheter device kit was returned for evaluation.Visual, microscopic and tactile evaluations were performed.The investigation is inconclusive for foreign material present in device, as the catheter was returned in two separate fragments.A dark, straight mark was observed on the catheter between the 32 and 33 depth markers.Another dark, straight mark line was observed approximately at the 55th depth marker.Since the kit was opened upon return it is unknown whether the mark could have been from clinical procedure, packaging return procedure or manufacturing error.The definitive root cause could not be determined based upon available information.It is unknown if manufacturing, shipping, or procedural procedurals contributed to the reported event.
Event or Problem Description
It was reported that prior to insertion, the physician noticed a 2-3 cm silver strip in the catheter.It was further reported that a new device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: per the lot history review, this is the first complaint reported for this lot number and issue to date.The quantity affected is one.Based upon the severity level and lot quantity, a dhr review is not required.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one ti lp powerport slim with 6 fr s/l polyurethane catheter device kit was returned for evaluation.Visual, microscopic and tactile evaluations were performed.The investigation is inconclusive for foreign material present in device, as the catheter was returned in two separate fragments.A dark, straight mark was observed on the catheter between the 32 and 33 depth markers.Another dark, straight mark line was observed approximately at the 55th depth marker.Since the kit was opened upon return it is unknown whether the mark could have been from clinical procedure, packaging return procedure or manufacturing error.The definitive root cause could not be determined based upon available information.It is unknown if manufacturing, shipping, or procedural procedurals contributed to the reported event.
Event or Problem Description
It was reported that prior to insertion, the physician noticed a 2-3 cm silver strip in the catheter.It was further reported that a new device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that prior to insertion, the physician noticed a 2-3 cm silver strip in the catheter.It was further reported that a new device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one photo from the complainant and one ti lp powerport slim with 6 fr s/l polyurethane catheter device kit was returned for evaluation.Visual, microscopic and tactile evaluations were performed.The investigation is inconclusive for foreign material present in device, as the catheter was returned in two separate fragments.A dark, straight mark was observed on the catheter between the 32 and 33 depth markers.Another dark, straight mark line was observed approximately at the 55th depth marker.Since the kit was opened upon return it is unknown whether the mark could have been from clinical procedure, packaging return procedure or manufacturing error.The definitive root cause could not be determined based upon available information.It is unknown if manufacturing, shipping, and/or procedural issues contributed to the reported event.H11: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.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT WITH ATTACHABLE 6F POLYURETHANE OPEN-ENDED
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7523551
• Report Number: 3006260740-2018-01003
• Device Sequence Number: 16470055
• Product Code: LJT
• UDI-Device Identifier: 00801741026768
• UDI-Public: (01)00801741026768
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1716070
• Device Catalogue Number: 1716070
• Device Lot Number: RECN2508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 02/27/2019; 03/11/2019; 04/02/2019
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 02/28/2019; 03/14/2019; 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1