MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC INTERMEDIATE TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refs0742 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refs0742) have been reported from the same facility.
Event or Problem Description
It was reported "we recently received a new batch of picc lines from bard.The previous lot numbers we had, had a replacement connector.We used those and had to order a new case of picc kits.Our crna was preforming a picc line today and the connector failed that was in the kits.Thank goodness we had extra of the connectors that bard sent out to place on our recalled kits.The crna was able to finish the picc line.I am letting you know that with these kits we recently received the connector failed." add info rcvd 09/23/2021: placement date: (b)(6) 2021.Placement info: picc line left upper arm.Was there patient harm reported?: no.

• Brand Name: GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC INTERMEDIATE TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12615940
• Report Number: 3006260740-2021-04329
• Device Sequence Number: 16467751
• Product Code: LJS
• UDI-Device Identifier: 00801741045097
• UDI-Public: (01)00801741045097
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K034020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 7617400
• Device Lot Number: REFS0742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other