MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "they were able to flush before accessing but once accessed needle was not flushing or aspirating.".
Additional Manufacturer Narrative
(b)(4).The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of asfyf085 showed two other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "they were able to flush before accessing but once accessed needle was not flushing or aspirating.".
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 an occluded infusion set was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 19ga x 1¿ powerloc safety infusion set with y-site.Usage residues were observed throughout the sample and the safety mechanism was engaged.Microscopic inspection of the sample did not reveal any evidence of occlusion.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.The effort required to flush the sample was comparable to that required for a similar non-complainant device.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15375226
• Report Number: 3006260740-2022-03493
• Device Sequence Number: 5613593
• Product Code: LJT
• UDI-Device Identifier: 00801741047893
• UDI-Public: (01)00801741047893
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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 Expiration Date: 05/21/2025
• Device Model Number: N/A
• Device Catalogue Number: 0671910
• Device Lot Number: ASFYF085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• 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