MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.5IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdxs0090 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the base of the safestep could not be moved when the nurse checked before use, then it was locked by spd.There was no reported patient contact.
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 inability to flush the infusion set was confirmed and the cause was determined to be supplier related.The product returned for evaluation was one 22ga x 0.75" safestep safety infusion set.The investigation findings were consistent with an adhesive occlusion, which occurred during device manufacture.The sample was functionally tested using water and a 12ml syringe, and a full occlusion was confirmed.Further examination of the sample revealed the following observations consistent with an adhesive occlusion: a clear substance was found at the extension tubing/needle joint; the occluding material fluoresced under ultraviolet light; lack of usage residue suggested the occluding material did not originate at the customer facility.From this, it was determined that the material was consistent with the adhesive used to assemble the device and appeared to have been deposited during device manufacture.The device is a supplied component.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported that the base of the safestep could not be moved when the nurse checked before use, then it was locked by spd.There was no reported patient contact.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G 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: 11142777
• Report Number: 3006260740-2021-00009
• Device Sequence Number: 2914713
• Product Code: FPA
• UDI-Device Identifier: 00801741066290
• UDI-Public: (01)00801741066290
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

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 Model Number: N/A
• Device Catalogue Number: LH-0035YN
• Device Lot Number: ASDXS0090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/28/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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