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

Model Number N/A

Device Problems Material Twisted/Bent (2981); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of asdqs190 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported the needle could not be retracted during removal.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; however, the root cause was not identified.The complaint of unable to activate safety mechanism was confirmed but the exact cause remains unknown.The product returned for evaluation was a one 20 ga x 0.75 in safestep infusion set.A photo sample of a safestep infusion set was also provided and appeared to correspond to the returned sample.The returned product sample was evaluated and the needle was observed to be bent at the needle shaft.The following observations were noted during the sample evaluation: the needle was bent at the region where the needle extends from the base.Microscopic examination of the sample found no supporting evidence of a specific root cause.A functional test of the safety mechanism found that the safety mechanism would not engage over the needle tip due to the bend within the needle.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; the manufacturing lot number that was provided is invalid.

Event Description

It was reported the needle could not be retracted during removal.No other information was provided.

• 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: 9596533
• MDR Text Key: 190995473
• Report Number: 3006260740-2020-00127
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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
• Device Lot Number: ASDQS190 (INVALID)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1