MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recw0500 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the patient that approx 1 month ago red port of picc came apart at red and white connection site, reinserted and continued to be used.On monday (b)(6) 2019 writer inspected picc and was able to disconnect easily red port.Picc removed and new picc inserted.Note that limited information was available as it was a report by the patient who came from home.
Event or Problem Description
It was reported by the patient that approx 1 month ago red port of picc came apart at red and white connection site, reinserted and continued to be used.On monday sep 30, 2019 writer inspected picc and was able to disconnect easily red port.Picc removed and new picc inserted.Note that limited information was available as it was a report by the patient who came from home.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a connector detachment is confirmed and appears to be related to the use of the device.One 5 fr dl groshong catheter was returned for investigation.Residual material was present within the catheter and on the surface of the luer hubs.A paper note was returned with product information lot: recw0500 and ref: (b)(4).The sample was returned with the red luer connector slightly removed from the white over-sleeve.Both lumens were flushed with water using a 12 ml syringe and were patent to infusion.The samples were pressurized, and no leaks were observed.An attempt to remove the red connector from the white over-sleeve revealed it to require excessive force for it to be successfully removed.Microscopic observation of the proximal end of the extension tubing revealed no apparent damage.Based on the condition of the returned sample and force required to detach the red hub, it is likely that excessive force or manipulation contributed to the reported event; therefore, the complaint is confirmed.A lot history review (lhr) of recw0500 showed no other similar product complaint(s) from this lot number.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY WITH SAFETY INTRODUCER
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9234643
• Report Number: 3006260740-2019-03328
• Device Sequence Number: 13550150
• Product Code: LJS
• UDI-Device Identifier: 00801741035401
• UDI-Public: (01)00801741035401
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: N/A
• Device Catalogue Number: 7927505
• Device Lot Number: RECW0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Event Location: Home
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1