MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PER-Q-CATH PLUS 4F SL PICC W/SAFETY EXCALIBUR INTRODUCER PUNCTUR-GUARD; 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	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redy1714 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when pre-flushing the catheter prior to placement, the catheter placement operator found that the catheter leaked water.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, 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 leaking catheter was inconclusive due to the nature of the submitted evidence.The product returned for evaluation was one photograph which depicted a 4fr s/l per-q-cath catheter.The t-lock assembly was attached to the luer adapter.Usage residues were visible on the catheter shaft.The catheter appeared to have been trimmed.No obvious leakage or damage was observed in the photograph.While no damage or evidence of leakage was confirmed though examination of the returned photograph, the implicated device could not be thoroughly examined or functionally evaluated.Consequently this complaint is inconclusive at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported that when pre-flushing the catheter prior to placement, the catheter placement operator found that the catheter leaked water.No other information was provided.

• Brand Name: PER-Q-CATH PLUS 4F SL PICC W/SAFETY EXCALIBUR INTRODUCER PUNCTUR-GUARD
• 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: 12410795
• Report Number: 3006260740-2021-03643
• Device Sequence Number: 5304549
• 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): 09/21/2021

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: REDY1714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2021
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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