MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asens0063 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that leak from y site.Customer change needle.No other information was provided.

Event Description

It was reported that leak from y site.Customer change needle.No other information was provided.

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, applicable previous investigation(s), applicable fmea documents, applicable manufacturing records, returned sample analysis, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak at the y-injection site was confirmed.One safestep huber needle set from batch # asens0063 was returned for evaluation.A visual evaluation showed no signs of damage.A functional test of the returned device revealed that the extension set tubing was patent to infusion and aspiration.Upon pressurizing the safestep infusion set, a small drop of water was visible at the y-site along the edge of the blue valve stem.A microscopic examination of the y-injection site valve revealed that the blue stem moved slightly according to the pressure to which it was exposed.A positive pressure caused the top of the stem to extend slightly from the white valve cap and any fluid that was positioned between the blue valve stem and the white valve cap appeared to be pushed out.No fluid bypassed the sealing edge of the blue valve stem during aspiration or infusion.Subjecting the infusion set to a sustained positive pressure revealed no continuous leaks at the y-site.Likewise, while the device was under a sustained negative pressure, no air entered the infusion set during aspiration.The product ifu warns, ¿needleless y-injection site valve may leak slightly at certain pressures resulting in a small bead of fluid on the valve.¿ h3 other text : evaluation findings are in section h.11.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN 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
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12674053
• MDR Text Key: 277722106
• Report Number: 3006260740-2021-04441
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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-0029YN
• Device Lot Number: ASENS0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other