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	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
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 redz0625 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported the all-in-one extension tube did not match the pqc totally and there is still be a risk of fluid leaks in the future.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 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 risk of a leak between the extension tube and the catheter was inconclusive due to the sample condition.Two photos were returned for evaluation of this complaint.The photos were of a proximal piece of a 4fr s/l per-q-cath catheter.The t-lock assembly was attached to the luer adaptor of the catheter.The stylet was removed from the t-lock assembly and a needleless injection cap was attached to the luer adaptor of the side tubing on the t-lock assembly.Since the fit between the extension set and the catheter could not be analyzed from the photos, no conclusions could be made about the potential for a leak.The ifu states, ¿do not use the device if there is any evidence of mechanical damage or leaking.¿ h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the all-in-one extension tube did not match the pqc totally and there is still be a risk of fluid leaks in the future.No other information was provided.

• 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: 11813526
• Report Number: 3006260740-2021-01802
• Device Sequence Number: 3792736
• 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): 07/14/2021

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: REDZ0625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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