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

Model Number N/A

Device Problems Misassembled (1398); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdws0142 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that needle disconnect from plate.No other information was 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 safety mechanism disconnection is confirmed and the cause was supplier-related.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set.Light usage residues were observed.The safety mechanism was received completely detached from the needle shaft.Microscopic inspection of the safety mechanism revealed that the metal sleeve appeared to be missing.The safety plate was disassembled, and the lack of a metal sleeve was confirmed.The safety plate detached from the needle because the metal sleeve was not present.It appeared that the sleeve was omitted during product assembly.The device is a supplied component; however, the implicated supplier no longer provides these devices.A lot history review (lhr) of asdws0142 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that needle disconnect from plate.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10314172
• MDR Text Key: 200058372
• Report Number: 3006260740-2020-02622
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASDWS0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1