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 Contamination /Decontamination Problem (2895)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported by the customer "a ¿hair¿ was found inside the packaging.No patient harm was caused.".

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 asgqf021 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.

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, complaint and lot history review, 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 a foreign material on an infusion set is confirmed; however, the exact cause is unknown.One 20 g x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation showed some use residue on the returned sample and a clear liquid within the tubing of the infusion set.White-colored fibers were observed on the plate of the safety mechanism of the returned sample.A microscopic observation revealed the fibers appeared to be stuck between the foam ring and the plastic plate of the safety mechanism.Insufficient evidence was found on the returned sample to determine when, where, or how the infusion set came into contact with the observed foreign material.

Event Description

It was reported by the customer "a ¿hair¿ was found inside the packaging.No patient harm was caused.".

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 manufacturer has received the sample and will evaluate.Results are expected soon.

Event Description

It was reported by the customer "a ¿hair¿ was found inside the packaging.No patient harm was caused.".

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.Initial report included the date of event june 07 2022 as provided by the complainant.The date of the event has been updated in this report to align with the date included in the medwatch received.

Event Description

It was reported by the customer "a ¿hair¿ was found inside the packaging.No patient harm was caused.".

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15059820
• MDR Text Key: 297152451
• Report Number: 3006260740-2022-02776
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0031
• Device Lot Number: ASGQF021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 08/31/2022; 10/14/2022
• Supplement Dates FDA Received: 07/29/2022; 09/02/2022; 10/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• 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