MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL SAFETY INTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	4134115
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
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 redw2590 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter ((b)(4)) in patient from neurosurgery department leaked fluids from the portion 1.5 cm beneath the wing three days after the placement.During catheter flushing, the fluids spouted from the catheter and blood could not be drawn.Normal infusion and blood draws could not be performed with the catheter.Therefore, a new catheter was placed in the patient.
Event or Problem Description
It was reported that the catheter (4134115) in patient from neurosurgery department leaked fluids from the portion 1.5 cm beneath the wing three days after the placement.During catheter flushing, the fluids spouted from the catheter and blood could not be drawn.Normal infusion and blood draws could not be performed with the catheter.Therefore, a new catheter was placed in the patient.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak in the catheter was confirmed but the cause is unknown.A video of an implanted 4fr s/l per-q-cath was returned for evaluation of this event.In the video, the catheter was flushed with a clear liquid.During infusion, a spraying leak could be seen emanating from the catheter, just distal of the molded suture wings.No specific visual characteristics about the leak site could be ascertained from the video.Although a leak could be confirmed, the exact cause could not be determined at this time from the returned video.Possible contributing factors could include damage from the inlaid stylet, sharp instrument damage, burst due to over-pressurization, tensile (pulling) damage, or material fatigue.H3 other text : evaluation findings are in section h.11.

• Brand Name: PER-Q-CATH PLUS 4F SL SAFETY INTRODUCER
• 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: 11386597
• Report Number: 3006260740-2021-00523
• Device Sequence Number: 14326943
• Product Code: LJS
• UDI-Device Identifier: 00801741074899
• UDI-Public: (01)00801741074899
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K954104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 4134115
• Device Catalogue Number: 4134115
• Device Lot Number: REDW2590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 01/30/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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