MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 320550

Device Problem Defective Component (2292)

Patient Problems Easy Bruising (4558); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) difficult to operate.The following information was provided by the initial reporter: also reported that it is difficult to depress the pen.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-may-2023.H6: investigation summary customer returned four 32ga x 4mm pen needles unopened, with the tear drop label in place.It was reported by the consumer that " the patient end needle bends during injection.Non patient end needle bends during injection.Bruises at the injection site.Also reported that it is difficult to depress the pen.Functionality test using the pen injector was performed on the four returned needles and no issues , or needle bending were observed.The returned samples were inspected to ensure that using them was as least harmful as intended.The outer diameters of these needles were measured, the results of which are featured below: 1.0.0094 in; 2.0.00935 in; 3.0.00945 in; 4.0.00920 in.All of the needles were measured within acceptable outer diameters for canula 32g tw : 0.0090¿ ¿ 0.0095.¿ the integrity of needle point was inspected using magnification and no defects were found.No debris was found at the tip of the needle.Flour was applied to the needle's cannulas to ensure that lubricant was present.Sufficient lubricant was found on all samples.No damage to the needles of any kind was observed and all functioned as intended.Hence, the alleged issue could not be confirmed.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Based on the samples received, embecta was able not to confirm the customer¿s indicated issue.The root cause cannot be determined since the issue was not confirmed.

Event Description

It was reported that the bd nano¿ 2nd gen pen needles 32g x 4mm (100 count) difficult to operate.The following information was provided by the initial reporter: also reported that it is difficult to depress the pen.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16790633
• MDR Text Key: 313775851
• Report Number: 9616656-2023-00392
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: (01)00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 1300017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• 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