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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
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 refz1118 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "supervisor as well as a lines inserter called me to let me know that the product above was faulty.She has placed thousands of these catheters and this one would not pierce through the patients skin.It was not the needle but appeared to be at the needle/catheter transition area.She said it seemed like a rough transition and instead of forcing it, she aborted this procedure and got a new product which placed with ease.".
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 difficult to insert catheter is confirmed but the exact cause could not be determined.Two photo samples of a powerglide pro catheter were provided for evaluation.The first image shows the product packaging which indicates lot: refz1118.The second image shows the distal end of the powerglide pro housing containing the needle and catheter.Deformation on the tip of the catheter appeared to be present; however, the characteristics of the deformation could not be closely inspected from the image.Based on the images provided, possible contributing factors include advancement against resistance and catheter tip taper damage.Since the deformation was noted on the catheter tip, the complaint is confirmed but the exact cause remains unknown at this time.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "supervisor as well as a lines inserter called me to let me know that the product above was faulty.She has placed thousands of these catheters and this one would not pierce through the patients skin.It was not the needle but appeared to be at the needle/catheter transition area.She said it seemed like a rough transition and instead of forcing it, she aborted this procedure and got a new product which placed with ease.".

• 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: 14401124
• Report Number: 3006260740-2022-01796
• Device Sequence Number: 12144506
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2022

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: REFZ1118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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 Sex: Unknown