MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 ascys0092 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the safestep needle was noted to be leaking.The needle was exchanged.
Event or Problem Description
It was reported that the safestep needle was noted to be leaking.The needle was exchanged.
Additional Manufacturer Narrative
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 a leaking infusion set was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 22ga x 0.75¿ powerloc safety infusion set.Usage residues were observed within the extension tubing.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.No leaks were observed during sustained (>15 seconds) hydraulic pressurization.Microscopic inspection of the sample did not reveal any evidence of leakage.No leakage or evidence of previous leakage was discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.The returned sample exhibited no evidence of the alleged event.The event is unconfirmed per the investigation results.Since no device malfunction occurred and there is no allegation of a serious injury to a patent, user, or other person, this event is deemed not reportable per 21 cfr part 803.

• Brand Name: POWERLOC SAFETY INFUSION SET 22G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8549055
• Report Number: 3006260740-2019-01138
• Device Sequence Number: 1857511
• Product Code: FPA
• UDI-Device Identifier: 00801741047794
• UDI-Public: (01)00801741047794
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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: 0652234
• Device Lot Number: ASCYS0092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1