MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC TRAY; 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on (b)(6) 2021.On (b)(6) 2021, it was found that the catheter connector was detached from the catheter.The device was removed and another new catheter was replaced.There was no reported patient injury.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken catheter was confirmed.The product returned for evaluation was one 5fr d/l groshong catheter.Usage residues were observed throughout the sample.The returned segment included the catheter shaft, which exhibited a complete break distal of the molded joint.The proximal segment, including the molded joint and extension tubes was not returned for evaluation.The break site appeared irregular.Microscopic inspection of the break revealed a dully granular fracture surface.Permanent deformation was observed at the break site.Tactile inspection of the sample revealed severe tensile weakness, necking and discoloration in the vicinity of the break.The break features, tensile weakness, necking and discoloration were consistent with material failure due to pulling stress.The location of the damage suggested that catheter securement, access and maintenance techniques may have contributed.
Event or Problem Description
It was reported that the patient had a groshong catheter implanted on (b)(6) 2021.On (b)(6) 2021, it was found that the catheter connector was detached from the catheter.The device was removed and another new catheter was replaced.There was no reported patient injury.

• Brand Name: GROSHONG NXT 5F DUAL-LUMEN REVERSE TAPER PICC BASIC 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: 12013041
• Report Number: 3006260740-2021-02335
• Device Sequence Number: 16943181
• Product Code: LJS
• UDI-Device Identifier: 00801741035401
• UDI-Public: (01)00801741035401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023374
• 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): 07/09/2021

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: 7927505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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