MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	7755305
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rezc2345 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that a picc line was inserted into a (b)(6) old patient on thursday (b)(6) 2016 as normal and dressed as intended.During the 24 hour dressing change, it was reported by the health care professional (hcp) that the catheter had separated from the connector.Patient had a 4fr picc inserted and there was no reported patient injury.
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 following were reviewed as part of this investigation: patient severity, trend 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 a catheter break was confirmed, and was found to be use related.The implicated and returned product was a 3 fr groshong catheter.The catheter was returned with the green connector piece assembled, and 4 mm of catheter extending beyond the connector piece.The blue oversleeve was not attached to the connector piece.The distal piece of returned catheter measured 27.8 cm in length, and contained the groshong valve.Residue was observed on the tip of the blue silicone oversleeve.Tactile examination showed tensile weakness and necking was present on the both segments of catheter near the break site.Microscopic examination showed granular surface characteristics on both sides of the catheter break surface.The catheter terminated in a somewhat planar break, with more granularity on one region of the break surface.The granular surface and tensile weakness are characteristic of tensile breaks.Tensile breaks can occur during day to day use of the catheter, or during removal of the catheter.The risk of tensile breaks can be mitigated by ensuring good securement of the catheter is achieved and excess catheter is not left outside the body.Risk of tensile break during removal can be mitigated by following the instructions for use.The instructions for use for removal instruct: ¿remove [catheter] slowly.Do not use excessive force.If resistance is felt, stop removal.Apply warm compress and wait 20-30 minutes.¿.

• Brand Name: GROSHONG 3 FR SINGLE-LUMEN PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5742287
• Report Number: 3006260740-2016-00288
• Device Sequence Number: 1048526
• Product Code: LJS
• UDI-Device Identifier: 00801741037757
• UDI-Public: (01)00801741037757(17)180328(10)REZC2345
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K926331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2016

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: 03/28/2018
• Device Catalogue Number: 7755305
• Device Lot Number: REZC2345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2016
• Supplement Report FDA Received Date: 07/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 MO