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

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of complications during aspiration were confirmed and the damage appeared to be supplier related.Two 22g safestep infusion sets with needleless injection y-site were returned for investigation.The samples exhibited evidence of use.A functional test revealed that air would continuously enter the infusion sets through the y-site and fill the syringe during aspiration.No continuous leak of fluid was observed in any part of the returned samples when the infusion set was pressurized with water.The valve was cut open and the valve stem was removed, which revealed damage to the sealing surface of the valve stem and other areas of the valve stem.The damage to the sealing surface of the valve stem was located in areas that were inaccessible to the user.The damage observed on the valve stem most likely allowed air to bypass the sealing surface of the valve stem during aspiration.Bd is working closely with the supplier to prevent recurrence of the reported event.A lot history review (lhr) of aseyf113 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (aseyf113) have been reported from the same facility in (b)(6).

Event Description

It was reported that when blood return was attempted to be confirmed after the device was accessed to the port body, there was a feeling of strangeness and there was little resistance during aspiration.The device was removed and the treatment was completed using another needle.There was no reported patient injury.On 07/12/2021: the returned samples exhibited damage to the sealing surface of the valve stem.Two devices were returned for evaluation.This report addresses sample 1.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN W/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: 12278045
• MDR Text Key: 265093635
• Report Number: 3006260740-2021-03148
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• 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: ASEYF113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2020
• 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