MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.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 leak was found on the connection site between hub and set after 3 days.

Event Description

It was reported that the leak was found on the connection site between hub and set after 3days.

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 damaged luer adapter was confirmed and the cause appears to be use related.The product returned for evaluation was a one 20ga x 0.75" safestep safety infusion set.The investigation findings are consistent with damage accumulated through gradual deformation due to continuous outward-radiating stress within the luer hub orifice, also known as material creep.Likely sources of the stress include slip-fit style male luer adapters such as those found on some i.V.Administration sets and syringes.The returned product sample was evaluated and the characteristics observed which supported this type of failure included: the luer hub orifice was found to be out of iso tolerance using a calibrated taper gauge.Usage residue was seen throughout the sample.Lack of mechanical damage on the luer hub.Attachment of the device to non-complainant slip-fit adapters was firm; however, the tapers could be fully inserted into the luer hub orifice.Attachment of the device to non-complainant luer-lock adapters was unremarkable.The evidence suggests that a tapered object was forcefully inserted into the luer hub orifice then left in place, resulting in gradual widening, or creep, of the luer hub material.This type of failure was replicated at bas using 5 iso compliant slip-fit adapters and 5 non-complainant infusion sets.A combination of use of slip-fit style adapters, the force with which those adapters were inserted, and the duration of insertion resulted in this type of slow luer hub deformation.Creep deformation takes place over days; however, the rate of deformation depends upon the force used to insert the taper.This type of damage may possibly be mitigated by reducing the insertion force and/or using luer-lock style adapters.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10190209
• MDR Text Key: 196271222
• Report Number: 3006260740-2020-02207
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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-0031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1