MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO FINE¿ + PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320136

Device Problem Misconnection (1399)

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

Event Date 03/14/2023

Event Type  malfunction  

Event Description

It was reported that the bd micro fine¿ + pen needle experienced (short description of event) the following information was provided by the initial reporter, translated from japanese to english: and a patient using teriparatide has a difficulty to connect to the injector.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary: two open 32g x 4mm pen needle samples and three photos were returned from an unknown lot.No., cat.No.320136.Visual examination was carried out on the returned samples and a bent non patient end of cannula was observed on both samples.A functionality test as per q-sop-183-dl was also carried out on the returned samples and no issues were observed.No dhr review can be carried out as lot number is unknown.As the samples returned were open it is not possible to determine root cause.

Event Description

It was reported that the bd micro fine¿ + pen needle experienced (short description of event).The following information was provided by the initial reporter, translated from japanese to english: and a patient using teriparatide has a difficulty to connect to the injector.

• Brand Name: BD MICRO FINE¿ + 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 ; 8448235433
• MDR Report Key: 16665650
• MDR Text Key: 312763310
• Report Number: 9616656-2023-00314
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• 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