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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "needle is dull, difficult to puncture vein." additional information received: it was reported "facility uses powerglide pro not the rt reinforced tip.The catheter is possibly fish mouthing when they advance, giving the impression that the needle is dull.".
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refx1586 showed two other similar product complaint(s) from this lot number.
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 difficult powerglide insertion was confirmed; however, the root cause not identified.The product returned for evaluation was two 18ga x 10cm powerglide pro midline catheters.The first sample (sample 1) comprised just the catheter.The housing assembly was not returned.Light usage residues were observed on the sample and the catheter shaft exhibited curved shape memory.The catheter tip appeared to exhibit deformation.Microscopic inspection of sample 1 confirmed deformation of the catheter tip.A non-complainant needle was inserted through the catheter.The tip of the catheter flared away from the needle shaft.The second sample (sample 2) was received in its original sealed packaging.Sample 2 appeared unremarkable to gross inspection.Microscopic inspection of sample 2 was unremarkable.The catheter tip appeared properly formed and did not deviate from the needle shaft.The used sample exhibited tip deformation that would likely cause resistance during attempted device insertion; however it could not be determined precisely when/how catheter tip damage occurred.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted insertion against resistance, such as into tissue and improper tip formation during device manufacture.The unused sample appeared unaffected.
Event or Problem Description
It was reported "needle is dull, difficult to puncture vein." additional information received: it was reported "facility uses powerglide pro not the rt reinforced tip.The catheter is possibly fish mouthing when they advance, giving the impression that the needle is dull.".

• 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: 13736901
• Report Number: 3006260740-2022-00753
• Device Sequence Number: 4839305
• Product Code: FOZ
• UDI-Device Identifier: 00801741110511
• UDI-Public: (01)00801741110511
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/25/2022

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: REFX1586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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