MAUDE Adverse Event Report: BECTON DICKINSON BD MICRO-FINE¿+ PEN NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320136

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/27/2023

Event Type  malfunction  

Event Description

It was reported that prior to using the bd micro-fine¿+ pen needles 32g x 4mm (70 count) the device was found missing a protective seal.The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about protective seal missing.Customer reported that one of the bags of #30136 (mfp32g4mm) was brought to the dispensary by a nurse at the aged care facility because it was missing a protective seal.Sold by the same dispensing pharmacy to a geriatric facility.Complaint from the same pharmacy.

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was able to confirm the customer indicated issue.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that prior to using the bd micro-fine¿+ pen needles 32g x 4mm (70 count) the device was found missing a protective seal.The following information was provided by the initial reporter, translated from japanese to english: this is a complaint about protective seal missing.Customer reported that one of the bags of #30136 (mfp32g4mm) was brought to the dispensary by a nurse at the aged care facility because it was missing a protective seal.Sold by the same dispensing pharmacy to a geriatric facility.Complaint from the same pharmacy.

Manufacturer Narrative

H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was able to confirm the customer indicated issue.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.H3 other text : see h.10.

• Brand Name: BD MICRO-FINE¿+ PEN NEEDLES
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18365117
• MDR Text Key: 331325406
• Report Number: 2243072-2023-02221
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1