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

Model Number N/A

Device Problems Separation Failure (2547); Activation Problem (4042)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdys0032 showed one other similar product complaint(s) from this lot number.Device not returned for evaluation.

Event Description

It was reported that when the nurse tried priming with saline solution and puncturing, it was found that the handle and base could not come off.Therefore, the nurse stopped using it.There was no reported patient involvement.

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, complaint and batch history, applicable previous investigation(s), sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a failed safety mechanism was confirmed and appears to be supplier related.The product returned for evaluation was a 22g x 0.75¿ safestep safety infusion set.The returned infusion set was patent to infusion.The safety mechanism was not engaged over the needle.When an attempt was made to advance the safety mechanism over the needle, the safety mechanism could not be slid along the needle.Microscopic examination revealed clear material on the top of the safety mechanism.When the sample was exposed to a uv light, the clear material illuminated.This clear material appears to be excess adhesive from the bonding of the needle to the handle/housing.This is a supplied component and the manufacturing this device has been moved to a different supplier since this lot was manufactured.

Event Description

It was reported that when the nurse tried priming with saline solution and puncturing, it was found that the handle and base could not come off.Therefore, the nurse stopped using it.There was no reported patient involvement.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
• 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: 11174363
• MDR Text Key: 228214926
• Report Number: 3006260740-2020-21330
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• 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-0029
• Device Lot Number: ASDYS0032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other