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 Material Deformation (2976); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

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 needle could not be retracted completely.No other information was provided.

Event Description

It was reported that the needle could not be retracted completely.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 failure was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 20ga x 0.75"safestep safety infsuion set.The returned product sample was evaluated and the needle was observed to be bent near the exit site from the non-engaged safety mechanism.The following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The needle tip was barbed suggesting contact between the needle and port base.The safety mechanism was successfully engaged; however, resistance was encountered when advancing the safety mechanism over the bent region of the needle shaft.Based on the evidence provided with the returned sample it is unknown when or how the bend occurred in the needle.Damage to the needle could have occurred at the manufacturing facility, during shipping, during use, or during storage of the product, and no evidence was observed which supported a specific root cause of the event.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 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: 9548907
• MDR Text Key: 181976452
• Report Number: 3006260740-2019-04062
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• 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-0031YN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1