MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Disconnection (1171)

Patient Problems Tissue Damage (2104); Patient Problem/Medical Problem (2688)

Event Date 10/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebt0201 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient was placed with a 7555405 catheter on (b)(6) 2018 under the operation of a nurse specialist from general surgery department and the catheterization process was smooth.During the period of hospitalization, maintenance and use were normal.During the maintenance on (b)(6) 2018, the whole catheter was disconnected from the connector.The catheter was intact and the connector was also intact.After the emergency consultation, the tourniquet was tied in time.Finally, after the multi-department consultation, it was considered that the blood vessel was damaged after the blood vessel was cut, and it can not be sutured very well.Finally the catheter was removed smoothly under intervention.

Manufacturer Narrative

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 detached catheter was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 4fr s/l groshong catheter.The sample was received with an assembled two-piece connector.The catheter was completely detached from the connector.Usage residues were evident throughout the sample.The proximal end of the catheter appeared unremarkable.Microscopic inspection of the proximal end of the catheter revealed a glossy and regularly striated texture consistent with a sharp instrument cut.The connector was disassembled and no catheter fragment or other evidence of catheter passage was observed.Following longitudinal bisection of the distal connector segment, inspection of the compression sleeve revealed that it had been advanced into the narrow region of the bore.Microscopic inspection of the compression sleeve confirmed that it had been advanced into the narrow region of the bore.The distal connector id was measured using a digital microscope and found to be outside of manufacturing specifications.The connector showed no evidence of catheter passage prior to assembly, suggesting that the catheter was not inserted past the compression sleeve during device placement.The distal connector id was found to be smaller than minimum specifications and likely contributed to difficulty/inability to properly insert the catheter.

Event Description

It was reported that the patient was placed with a 7555405 catheter on august 20, 2018 under the operation of a nurse specialist from general surgery department and the catheterization process was smooth.During the period of hospitalization, maintenance and use were normal.During the maintenance on october 8, 2018, the whole catheter was disconnected from the connector.The catheter was intact and the connector was also intact.After the emergency consultation, the tourniquet was tied in time.Finally, after the multi-department consultation, it was considered that the blood vessel was damaged after the blood vessel was cut, and it can not be sutured very well.Finally the catheter was removed smoothly under intervention.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER)
• Type of Device: 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: 8027975
• MDR Text Key: 126155882
• Report Number: 3006260740-2018-03059
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741035272
• UDI-Public: (01)00801741035272
• Combination Product (y/n): N
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7655405
• Device Lot Number: REBT0201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 30