MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 320550

Device Problem Component Misassembled (4004)

Patient Problems Erythema (1840); Skin Inflammation/ Irritation (4545)

Event Date 02/04/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0231155.Medical device expiration date: 08/31/2025.Device manufacture date: 08/18/2020.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 3 boxes of bd nano¿ 2nd gen pen needles had insufficient cannula length.The following information was provided by the initial reporter: "it was reported that consumer is getting a bubble under the skin at injection site and red marks.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0231155.Medical device expiration date: 08/31/2025.Device manufacture date: 08/18/2020.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 3 boxes of bd nano¿ 2nd gen pen needles had insufficient cannula length.The following information was provided by the initial reporter: "it was reported that consumer is getting a bubble under the skin at injection site and red marks.".

Event Description

It was reported 3 boxes of bd nano¿ 2nd gen pen needles had insufficient cannula length.The following information was provided by the initial reporter: "it was reported that consumer is getting a bubble under the skin at injection site and red marks.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 24-feb-2022.H.6.Investigation: customer returned 5 unopened 4mm, 32 gauge nano pro pen needles from lot 1082129.Visual inspection of the available pen needles found a foreign material on the needle in 3 of 5 pen needles returned despite the pen needles not being used prior to inspection.No other defects were observed.All of the needles were measured at 0.0092 in, which is within acceptable outer diameters for 32 gauge needles (0.0090 in to 0.0095 in).The integrity of the needle points were inspected and no defects were found.However, the material present on the needles would interfere with regular use.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, bd was able to confirm the customer¿s indicated failure of skin irritation due to the presence of foreign material on the needles.As per request, ftir analysis was completed on the material observed on the patient end of the cannula.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.Root cause could not be determined.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• 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 ; 8015296192
• MDR Report Key: 13546050
• MDR Text Key: 285742915
• Report Number: 9616656-2022-00190
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182320
• 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: 04/25/2022

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: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/16/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 05/04/2022
• 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