MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asfyf070 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported on removal, the retraction system did not fully deploy causing the nurse to be pricked.

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.H3 other text : device not returned.

Event Description

It was reported on removal, the retraction system did not fully deploy causing the nurse to be pricked.Additional information: the event occurred after removing a needle from the patient.The affected nurse required labs/monitoring but no prophylactic or therapeutic treatment.The affected nurse has recovered.The patient on whom the needle was used did not have blood borne diseases.

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, applicable previous investigation(s), sample (if available), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty activating a safety mechanism is inconclusive due to the state of the returned sample.One 20 g x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation showed a small amount of use residue on the returned sample.The safety mechanism of the returned device was found to be engaged over the needle tip.No bends were found in the needle shaft, and a microscopic observation revealed the needle tip was undamaged.The safety mechanism was able to be deactivated and reactivated without any notable resistance.While no damage, defect, or other issue could be found on the safety mechanism of the returned sample, environmental conditions, buildup of residue on the device, and/or de-accessing technique could have contributed to the reported difficulty activating the safety mechanism.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported on removal, the retraction system did not fully deploy causing the nurse to be pricked.Additional information: the event occurred after removing a needle from the patient.The affected nurse required labs/monitoring but no prophylactic or therapeutic treatment.The affected nurse has recovered.The patient on whom the needle was used did not have blood borne diseases.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15835169
• MDR Text Key: 304027463
• Report Number: 3006260740-2022-05410
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0031
• Device Lot Number: ASFYF070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 02/03/2023
• Supplement Dates FDA Received: 12/02/2022; 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention