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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2022
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 (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "writer aspirated cathflo from white lumen of patient's picc, without issue, then flushed with 10 ml normal saline with ease.Using same amount of even pressure, when attempting to flush 2nd 10 ml syringe of ns, "popping" sound heard; catheter blew and separated - such that catheter tip still connected with syringe in writer's hand- but catheter end still connected to patient, open to air.(the catheter split in 2).Writer immediately pinched off catheter end still connected to patient." additional information provided 10/12/22: insertion: date & time: (b)(6) 2022, 09:33.External length: 4 cm.Total catheter length: 46 cm.Site: right arm and basilic.Insertion site above anticubital: 10 cm.Arm circumference: 30 cm.Initial securement device: securacath.Number of attempts: 1.What type of catheter securement was utilized? securacath.What they¿re being treated for: myeloma.Does the patient have an infectious disease? no.
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 damaged 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 break was observed in the white-luered extension tubing, just distal of the strain-relief sleeve.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 'c' shaped break profile 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 catheter deformation and two permanent kink impressions were observed between the 39cm and 41cm depth markings.Such damage may contribute to catheter occlusion and may be related to use of a compression stylet catheter securement device.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.
Event or Problem Description
It was reported by the customer "writer aspirated cathflo from white lumen of patient's picc, without issue, then flushed with 10 ml normal saline with ease.Using same amount of even pressure, when attempting to flush 2nd 10 ml syringe of ns, "popping" sound heard; catheter blew and separated - such that catheter tip still connected with syringe in writer's hand- but catheter end still connected to patient, open to air.(the catheter split in 2).Writer immediately pinched off catheter end still connected to patient." additional information provided 10/12/22: insertion: date & time: (b)(6) 2022 09:33.External length: 4 cm.Total catheter length: 46 cm.Site: right arm and basilic.Insertion site above anticubital: 10 cm.Arm circumference: 30 cm.Initial securement device: securacath.Number of attempts: 1.What type of catheter securement was utilized? securacath what they¿re being treated for: myeloma *does the patient have an infectious disease? no.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15608680
• Report Number: 3006260740-2022-04023
• Device Sequence Number: 15246099
• Product Code: LJS
• UDI-Device Identifier: 00801741035388
• UDI-Public: (01)00801741035388
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 7857505
• Device Lot Number: REFZ2156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Age: 47 YR
• Patient Sex: Unknown
• Patient Weight: 83 KG