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

Model Number N/A

Device Problems Material Separation (1562); Activation Problem (4042)

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

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asens0080 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during removal, the needle separated with the needle base.Removed needle.

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), labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached safety mechanism was confirmed but the cause is unknown.The product returned for evaluation was a 22g x 0.75¿ safestep safety infusion set with y-site.Adhesive residue was found along the length of the sample and dried red residual material was seen within the safety mechanism.The safety mechanism was not engaged over the needle but was instead completely separated from the device.The spring shields had closed over the needle hole.Both the black insert base and metal needle capture sleeve were seen in the safety mechanism.The safestep needle capture sleeve was removed from the safety mechanism by the investigator.It appeared unremarkable to microscopic visual examination.The length and inner diameter of the sleeve were measured and found to meet the device specifications.Microscopic examination was conducted on the needle.Light longitudinal score marks that were seen along the needle.These were likely the result of the safety mechanism capture sleeve rubbing against the needle cannula.The needle outer diameter and the distance between the bevel plane and the needle shaft plane were measured and found to meet the device specifications.The exact root cause for the detached safety mechanism could not be determined at this time.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that during removal, the needle separated with the needle base.Removed needle.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN 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: 10992689
• MDR Text Key: 221534012
• Report Number: 3006260740-2020-20854
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• PMA/PMN Number: K040527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: LH-0029YN
• Device Lot Number: ASENS0080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other