MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT 5F DL REVERSE TAPER PICC BT W/SAFETY INTRODUCER (45CM); 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	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reet2300 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that 4 fr groshong double lumen picc line punctured.No other information was provided.
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 leak is confirmed.One 5 fr dual lumen groshong nxt catheter, one excalibur introducer, one statlock device in a sealed pouch, one attachable suture wing in a sealed pouch, one stiffening stylet, and one t-lock were returned for evaluation.An initial visual observation showed use residue on the returned sample.A large longitudinal split was observed in the white lumen of the catheter near the 43 cm depth marker.Some tensile weakness was observed in the catheter directly around the location of the split.A microscopic observation revealed the edges of the split were rough and uneven but mostly straight and the fracture surfaces were mostly flat with a granular surface texture.Some whitening of the catheter material was observed on the fracture surfaces, suggesting a tearing failure mode.The observed characteristics of the split found in the returned catheter, as well as the presence of tensile weakness around the leak site, indicate the split was most likely caused by burst damage due to over-pressurization of the catheter.The product ifu states: ¿do not flush against resistance.If the lumen will neither flush nor aspirate and it has been determined that the catheter is occluded with blood, a declotting procedure per institution protocol may be appropriate.¿ h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that 4 fr groshong double lumen picc line punctured.No other information was provided.

• Brand Name: GROSHONG NXT 5F DL REVERSE TAPER PICC BT W/SAFETY INTRODUCER (45CM)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12901677
• Report Number: 3006260740-2021-05053
• Device Sequence Number: 5095177
• Product Code: LJS
• UDI-Device Identifier: 00801741035340
• UDI-Public: (01)00801741035340
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K023374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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 Model Number: N/A
• Device Catalogue Number: 7827505
• Device Lot Number: REET2300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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