MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number LH-0035

Device Problems Detachment of Device or Device Component (2907); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

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 when the patient¿s family tried to remove the safestep from the port body after infusion of an anti-cancer agent was completed, the base could not secure the needle tip and slipped off from the needle.There was no reported patient injury.

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 safety mechanism detachment was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 0.5¿ safestep safety infusion set.The sample was received without the safety mechanism plate.Usage residues were observed.Microscopic inspection of the sample revealed longitudinally aligned scoring marks along the needle shaft.The needle bevel angle was measured to be about 8 degrees.A similar non-complainant device was measured and the bevel angle was found to be about 13 degrees.The safety mechanism was removed by forceful pulling, and the angle was subsequently measured to be about 8 degrees.The scoring marks and reduced bevel angle were consistent with forceful removal of the safety mechanism.The usage residues suggested that exposure occurred during or following device removal from the patient.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 when the patient¿s family tried to remove the safestep from the port body after infusion of an anti-cancer agent was completed, the base could not secure the needle tip and slipped off from the needle.There was no reported patient injury.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.5IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8896975
• MDR Text Key: 154793172
• Report Number: 3006260740-2019-02405
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066283
• UDI-Public: (01)00801741066283
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

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: Lay User/Patient
• Device Model Number: LH-0035
• Device Catalogue Number: LH-0035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Event Location: Home
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 09/23/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1