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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the picc was inserted on the 14th june.On the 4th july, while flushing the picc, the ward nurse noticed that the proximal (red) lumen had split.The split was located below the wings near the blue catheter.There was no visible split in the distal (white) lumen.The nurse may have applied too much pressure while flushing ie not using the correct size syringe to flush or incorrect flushing technique.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx5265 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc was inserted on the 14th june.On the 4th july, while flushing the picc, the ward nurse noticed that the proximal (red) lumen had split.The split was located below the wings near the blue catheter.There was no visible split in the distal (white) lumen.The nurse may have applied too much pressure while flushing ie not using the correct size syringe to flush or incorrect flushing technique.
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 leaking catheter was confirmed.The product returned for evaluation was one 5fr d/l groshong catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed in the red-luered lumen, just distal of the molded joint.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: ¿ 's' shaped split ¿ tensile weakness at the fracture site (due to material ballooning prior to burst) ¿ granular fracture surface texture (typical of tearing failure modes) ¿ the catheter material was visibly lighter in color at the fracture site an examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15122809
• Report Number: 3006260740-2022-02927
• Device Sequence Number: 20663571
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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 Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 7857505
• Device Lot Number: REFX5265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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