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

Catalog Number LH-0029

Device Problems Crack (1135); Fluid/Blood Leak (1250); Gas/Air Leak (2946)

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

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the extension tubing filled with air and then blood was noted to be leaking out the joint where the tubing connects to the needle section.A crack was noted in this section.No other information was not 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, 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 a leaking infusion set was confirmed.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set.Usage residues were observed throughout the sample and the safety mechanism was engaged.A needleless injection cap was attached to the luer adapter.A partially circumferential split was observed at the luer/tubing joint.Microscopic inspection of the split revealed a dully granular fracture surface.Beach marks and radiating tear marks were observed throughout the fracture surface.Deformation and discoloration were observed in the vicinity of the split.The fracture features were consistent with material fatigue, suggesting that damage was accumulated through repetitive mechanical stresses such as twisting and bending; however, an additional factor(s) may have contributed.The device is a supplied component and the supplier has been notified of this event.

Event Description

It was reported that the extension tubing filled with air and then blood was noted to be leaking out the joint where the tubing connects to the needle section.A crack was noted in this section.No other information was not provided.

• 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: 11349425
• MDR Text Key: 234212118
• Report Number: 3006260740-2021-00399
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/18/2021

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 Catalogue Number: LH-0029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/19/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other