MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.5IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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 asdys0022 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "the needle does not get fixed to its hub, it's loose, leading to an instability and jeopardizing its functionality." no other information was provided.
Event or Problem Description
It was reported that "the needle does not get fixed to its hub, it's loose, leading to an instability and jeopardizing its functionality." no other information was provided.
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 a damaged infusions set was inconclusive because the returned sample appeared to be a sealed lot sample and not the originally implicated device.The product returned for evaluation was one 20ga x 0.5¿ safestep safety infusion set.The sample was received in its original sealed packaging.Following removal from the packaging, inspection of the sample was unremarkable.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.Tactile inspection of the sample was unremarkable.Microscopic inspection of the device joints was unremarkable.Attachments of several different luer accessories to the luer adapter were successful and unremarkable.No device deficiencies were discovered during evaluation of the returned sample; however, the sealed state of the packaging suggested that the sample was not the device implicated in the event description.Consequently this complaint is inconclusive at this time.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.5IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11529106
• Report Number: 3006260740-2021-00881
• Device Sequence Number: 3791311
• Product Code: FPA
• UDI-Device Identifier: 00801741066337
• UDI-Public: (01)00801741066337
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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 Expiration Date: 10/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0037YN
• Device Lot Number: ASDYS0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other