MAUDE Adverse Event Report: 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 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asfpf002 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "we have one item with a hair (or at least it appears to be a hair) in the sterile package." no other information was provided.

Event Description

It was reported "we have one item with a hair (or at least it appears to be a hair) in the sterile package." 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 a hair in the sealed package was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set.The sample was received in its original sealed packaging.The seal was intact and unremarkable.A hair-like fiber was visible within the packaging, apparently adhered to the luer adapter.The sealed state of the device packaging indicated that the fiber had been deposited on the device prior to packaging sealing, during device manufacture.The device is a supplied component and the supplier has been notified of this event.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12315902
• MDR Text Key: 266311267
• Report Number: 3006260740-2021-03278
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

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: ASFPF002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/19/2021
• Supplement Dates FDA Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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): Other