MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR INTRODUCER; 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	02/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a 4fr s/l per-q-cath was returned for evaluation of this event.The catheter appeared unused as it was free of residual material and the stylet was still partially inlaid.A length of the stylet had been retracted through the t-lock assembly.In the video, the catheter was flushed with a clear liquid through the t-lock extension tubing.During infusion, a bubbling leak could be seen emanating from the catheter, between the molded suture wings and the 1cm depth marking.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, or tensile (pulling) damage.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 when the pqc catheter was pre-flushed in the process of placement on (b)(6) 2021, fluids were seen leaking from the 0 scale.No other information was provided.

• Brand Name: PER-Q-CATH PLUS 4F SINGLE-LUMEN PICC WITH SAFETY EXCALIBUR 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: 11423223
• Report Number: 3006260740-2021-00642
• Device Sequence Number: 3882583
• 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
• Report Date (Section B): 02/17/2021

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: 4134115
• Device Lot Number: REDW2590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2021
• Initial Report FDA Received Date: 03/05/2021
• 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