MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE 4F CATHETER FULL TRAY (SINGLE-LUMEN) (60CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Misassembled (1398)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by healthcare professional "vat was consulted to assess leaking picc.Dressing was removed and flush attempted, fluid leaking from site.Taper of catheter noted to be hubbed into the skin.In attempt to save the line, i attempted to retract the picc to allow for repair, when the taper was removed it was noted the blue catheter was not longer connected and was not visible.I was unable to remove the catheter, site was cleaned and a guardiva was applied and covered with a tegaderm.Spoke with apn and recommended stat portable x ray to locate a potential intravascular foreign body.Also contacted ir to make her aware of the situation and she was going to talk with one of the ir attendings.Pt ended up need to go to ir for a intravascular foreign body removal." on 08/12/2021: what type of catheter securement was utilized? bd stat-lock picc plus #vppbfp.Placement date: (b)(6) 2021 @1005.
Event or Problem Description
It was reported by healthcare professional "vat was consulted to assess leaking picc.Dressing was removed and flush attempted, fluid leaking from site.Taper of catheter noted to be hubbed into the skin.In attempt to save the line, i attempted to retract the picc to allow for repair, when the taper was removed it was noted the blue catheter was not longer connected and was not visible.I was unable to remove the catheter, site was cleaned and a guardiva was applied and covered with a tegaderm.Spoke with apn and recommended stat portable x ray to locate a potential intravascular foreign body.Also contacted ir to make her aware of the situation and she was going to talk with one of the ir attendings.Pt ended up need to go to ir for a intravascular foreign body removal." 08/12/2021: what type of catheter securement was utilized? bd stat-lock picc plus #vppbfp placement date: (b)(6) 21 @1005.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a disconnected catheter is confirmed.One 4 fr two-piece groshong nxt connector was returned for evaluation.An initial visual observation showed use residue on the returned sample, and the connector was returned assembled.No catheter segments could be seen within the connector.A microscopic observation revealed no major damage on the connector pieces.The connector was disassembled and the distal connector piece was bisected.No catheter segments were found within the connector, and the compression sleeve was found to be advanced.Blood residue was observed throughout the interior of the distal connector piece and on the cannula of the proximal connector piece with distinct lines indicating where the compression sleeve and catheter were likely situated prior to their separation.The amount and location of this blood residue suggests the catheter may not have been positioned correctly on the cannula of the proximal connector piece.The proper position of the proximal end of the catheter on the cannula of the proximal connector piece is up against the grey-colored plastic body of the connector piece.This correct positioning ensures engagement of the compression sleeve within the distal connector piece which secures the catheter to the connector.In regard to assembly of the catheter and the connector pieces, the product ifu states: ¿gently advance the catheter onto the connector blunt until it butts up against the colored plastic body.The catheter should lie flat on the blunt without any kinks.¿ h3 other text: evaluation findings are in section h11.

• Brand Name: GROSHONG NXT CLEARVUE 4F CATHETER FULL TRAY (SINGLE-LUMEN) (60CM)
• 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: 12392511
• Report Number: 3006260740-2021-03617
• Device Sequence Number: 5360320
• Product Code: LJS
• UDI-Device Identifier: 00801741035241
• UDI-Public: (01)00801741035241
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7617407
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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: Required Intervention
• Patient Age: 14 YR