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); Misassembled (1398)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/25/2021
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 redv1285 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported: "during the hyper-pressure flushing, the system between the catheter holder and the catheter became detached.Clinical consequence observed: removal of the device.Pressure point the hemorrhagic area.Establishment of a new parenteral feeding system ".
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 detached catheter was confirmed and the cause appeared to be manufacturing-related.The product returned for evaluation was one 4fr s/l groshong catheter.Usage residue were observed throughout the sample.The catheter was received fully detached from the assembled two-piece connector.Microscopic inspection of the outside of the connector did not reveal any mechanical damage.Following disassembly of the connector, inspection of the metal cannula revealed abundant blood residue.No compression sleeve was observed.Following longitudinal bisection of the distal connector segment, the compression sleeve was confirmed to be missing.No mechanical damage was observed.The catheter detachment was caused by the lack of a compression sleeve within the distal connector segment.The lack of mechanical damage or other evidence of potential mis-handling suggested that the sleeve may have been omitted during device assembly.Photographs of the sample have been forwarded to the manufacturing site.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported: "during the hyper-pressure flushing, the system between the catheter holder and the catheter became detached.Clinical consequence observed: removal of the device.Pressure point the hemorrhagic area.Establishment of a new parenteral feeding system ".

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12183450
• Report Number: 3006260740-2021-02806
• Device Sequence Number: 20005192
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 7857505
• Device Lot Number: REDV1285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown