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	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redw0338 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported patients use picc catheters for chemotherapy, and maintenance is performed once a week.During maintenance in the outpatient operating room at 10 am on (b)(6) 2021, blood returning from the pipeline was found at 10:03, causing blockage of the uterine cavity.After communicating with the head nurse of the nail breast surgery department at 10:05, the patient returned to the ward with urokinase thrombolysis and flushing.The flushing was successful at 6:10 pm.

• 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: 11644886
• Report Number: 3006260740-2021-01261
• Device Sequence Number: 16918926
• 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: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2021

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: REDW0338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/09/2021
• 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
• Patient Age: 45 YR