MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE HYPODERMIC NEEDLE 30G X 0.5" YELLOW ¿

Catalog Number 304000

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Visual Impairment (2138)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone # (b)(6).Pma / 510(k)#: this device does not have a 510(k)#.Device manufacture date: 11/2015.Device evaluation: it is unknown if a sample is available for evaluation.A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that the needle of the suspect device broke off into a patient's eye.The patient went to (b)(6) and had an examination and b scan of the eye but the needle was not detected.Regarding follow up on the patient's condition, it is reported that the patient returned to (b)(6) hospital and continued her treatment of intravitreal injection.Her vision was impaired.No surgical intervention was performed.

Event Description

The needle snapped off about 5 or 6 mm away from the bevel.

Manufacturer Narrative

Device evaluation: result - a sample was not returned for evaluation.A photo was available for evaluation.Although the returned photo is not clear enough to identify the defect issue, the difference in cannula length is confirmed.(b)(4).Conclusion - bd was able to duplicate or confirm the customer's indicated failure mode.The returned photo shows a shorter cannula.Since the returned photo is not clear enough to identify the defect issue, and an actual sample was not returned for evaluation, an absolute root cause for this incident cannot be determined.(b)(4).Therefore, based on production record did not reveal any issue during production and no historical record of broken cannula during the cannula manufacturing were reported before, it is not possible to conclude that the root cause of the reported issue is related to the needle manufacturing process.See manufacturer narrative.

• Brand Name: BD MICROLANCE HYPODERMIC NEEDLE 30G X 0.5" YELLOW ¿
• Type of Device: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5511844
• MDR Text Key: 40776306
• Report Number: 3002682307-2016-00004
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 304000
• Device Lot Number: 151124
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2016
• Initial Date FDA Received: 03/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/21/2016; 04/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention