MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SLIMPORT M.R.I. ULTRA LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX; SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT & CATHETER

Model Number	0655640
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reaw1020 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire that was in the installation kit did not pass through the needle.On 3/8/2018 - returned wire was found to be kinked.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of difficulty passing a guidewire through a needle is confirmed and was determined to be use related.One 0.018 in.Guidewire in a plastic hoop, one 0.035 in.J-tip guidewire in a plastic hoop, and one 21 g introducer needle were returned for evaluation.An initial visual observation showed the distal end of the 0.018 in.Guidewire was bent and curved in multiple locations.Blood residue was observed on the 0.018 in.Guidewire and its hoop.The core wires of both guidewires did not appear to be broken during tactile evaluation.A microscopic observation revealed the outer coiled wire of the 0.018 in.Guidewire was unraveled at the most severe bend in the coiled section of the guidewire at the distal end.Some damage was observed on the core to coil interface of the 0.018 in.Guidewire.An attempt was made to pass a non-complaint 0.018 in.Guidewire through the returned 21 g introducer needle and the guidewire was able to be passed with ease.The returned 0.018 in.Guidewire was also able to be passed through the returned 21 g introducer needle, although some difficulty was observed when the bent sections of the guidewire entered the needle cannula.The kinks and bends in the 0.018 in.Guidewire made it difficult to pass the guidewire through the needle and, due to the amount of blood residue and the extent of damage observed, it is most-likely that the guidewire was damaged during use.A lot history review (lhr) of reaw1020 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the guidewire that was in the installation kit did not pass through the needle and it was kinked.No patient injury reported.

• Brand Name: SLIMPORT M.R.I. ULTRA LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 6F CHRONOFLEX
• Common Device Name: SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT & CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7382876
• Report Number: 3006260740-2018-00538
• Device Sequence Number: 13733468
• Product Code: LJT
• UDI-Device Identifier: 00801741026324
• UDI-Public: (01)00801741026324
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2018

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 Expiration Date: 08/31/2020
• Device Model Number: 0655640
• Device Catalogue Number: 0655640
• Device Lot Number: REAW1020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR