MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 20G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Additional 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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by customer that the patient states she has a powerport that she uses for normal saline infusions and zofran administration only.Her port stays accessed and the needle is changed every week.On (b)(6) 2023, she noticed there was air in the extension tubing this time due to the non-coring needle tubing again cracking where the tubing meets the luer hub.Patient provided the product code lh0037 and lot number asgufc010.Confirmed with patient they lock her port with heparin after each use with the bd posiflush heparin 100 units per ml, 3 ml total.They do not use any ethanol locking solution.The needleless connector they are using is the icu medical microclave.Patient did state they clean the needleless connector with alcohol before each use, however they do not tend to get it on the safestep extension tubing.Informed patient we will forward this to our product complaints team to investigate.Patient does have a sample of the product that has cracked, suggested she hold onto this to send in but engage the safety mechanism for safe handling.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.This complaint was received as part of a clinical survey.Contact information and specific patient details were not disclosed as part of the survey.As such, additional information and the subject sample cannot be obtained.
Event or Problem Description
It was reported by customer that the patient states she has a powerport that she uses for normal saline infusions and zofran administration only.Her port stays accessed and the needle is changed every week.On (b)(6) 2023, she noticed there was air in the extension tubing this time due to the non-coring needle tubing again cracking where the tubing meets the luer hub.Patient provided the product code lh0037 and lot number asgufc010.Confirmed with patient they lock her port with heparin after each use with the bd posiflush heparin 100 units per ml, 3 ml total.They do not use any ethanol locking solution.The needleless connector they are using is the icu medical microclave.Patient did state they clean the needleless connector with alcohol before each use, however they do not tend to get it on the safestep extension tubing.Informed patient we will forward this to our product complaints team to investigate.Patient does have a sample of the product that has cracked, suggested she hold onto this to send in but engage the safety mechanism for safe handling.Additional information received 15 september 2023: event did not interrupt treatment or cause a clinically significant delay.Ondansetron, normal saline were infusing, or planned to be infused.Patient believes tagaderm was used to secure device.When the tubing broke it allowed air to back up into the tubing.Break was external.No pieces retained in patient.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.5IN
• Common Device Name: 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 UT 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17726352
• Report Number: 3006260740-2023-04027
• Device Sequence Number: 12362215
• Product Code: FPA
• UDI-Device Identifier: 00801741066320
• UDI-Public: (01)00801741066320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: LH-0037
• Device Lot Number: ASGUFC010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Race: White