MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PG PRO 18G 10CM BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/11/2021
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 reeu2440 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reeu2440) have been reported from the same facility.
Event or Problem Description
It was reported 2 instances of catheters having blunt tips leading bending and failure of placing line.Add info rcvd (b)(6) 2021: none of the hematomas required surgical intervention.Placement info: dull tip, unable to place.Was there patient harm reported?: hematoma at site.What they¿re being treated for: hemolytic uremic syndrome.Medwatch mw5103282 rcvd (b)(6) 2021: bard midline 18g powerglide pro, blunt end, 2 failed attempts due to defect of blunt tip to catheter, successful 3rd attempt.This report addresses the second device.

• Brand Name: PG PRO 18G 10CM BASIC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12804766
• Report Number: 3006260740-2021-04842
• Device Sequence Number: 21283330
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: F118100
• Device Lot Number: REEU2440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 YR
• Patient Sex: Female