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

Device Problems Obstruction of Flow (2423); Positioning Problem (3009)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

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 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.

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 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11142777
• MDR Text Key: 227133533
• Report Number: 3006260740-2021-00009
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066290
• UDI-Public: (01)00801741066290
• Combination Product (y/n): N
• PMA/PMN Number: K040527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other