MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

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 leak from y site.Customer change needle.No other information was provided.

Event Description

It was reported that leak from y site.Customer change needle.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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a y-site leak is confirmed but the exact cause remains unknown.One safestep infusion set was returned for evaluation.The infusion set was flushed and pressurized from the proximal connector.A spraying leak was observed to emanate from the y-site valve.Microscopic observation of the y-site connector did not reveal any apparent damage on the housing or blue septum.An attempt to remove the valve from the connector was made in order to inspect the sealing surfaces; however, damage to the valve occurred during disassembly of the components.Since the infusion set was observed to leak and no damage was noted on the outer portion of the blue septum, the complaint is confirmed but the exact factors remain unknown at this time.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75 IN WITH Y-SITE
• 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12672395
• MDR Text Key: 277634392
• Report Number: 3006260740-2021-04430
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• 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-0029YN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other