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 Problem Failure to Infuse (2340)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

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 infusion set malfunction was confirmed; however, the root cause was not identified.The product returned for evaluation was one 22ga x 0.5¿ safestep safety infusions set with y-site.The sample was received with the safety mechanism engaged.No obvious use residues were observed.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during aspiration, some air was withdrawn into the syringe.The air aspiration was isolated to the valve by clamping the sample at various points on both extension tubes.Microscopic inspection of the valve septum revealed a gap between the valve septum and the valve housing.Inspection of the septum revealed deformation that appeared consistent with mechanical damage.The gap between the valve septum and housing may have caused/contributed to the observed air aspiration.The septum features suggested that mechanical damage may have contributed; however, the source of that damage/gap was not identified.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of asezf011 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when the needle was connected to the syringe and attempted to be primed, air could not be replaced and air bubbles could not be come out.There was no reported patient involvement.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15880336
• MDR Text Key: 307696137
• Report Number: 3006260740-2022-05520
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066290
• UDI-Public: (01)00801741066290
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: N/A
• Device Catalogue Number: LH-0035YN
• Device Lot Number: ASEZF011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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