MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 30 G X 1/2 IN. BD¿ BULK, NON-STERILE NEEDLE; HYPODERMIC NEEDLE

Catalog Number 302047

Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2017

Event Type  malfunction  

Manufacturer Narrative

Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.H results: the complaints lab received one samples.The samples were inspected under a microscope.White fm was observed attached the shaft of the cannula.It was glossy in nature.A small amount was removed for ftir.Ftir reviled that the fm was cellophane.Conclusion: although the customer's reported defect was confirmed, an absolute root cause for this incident cannot be determined.Udi# (b)(4).

Event Description

It was reported that the consumer observed an embedded particle on the cannula of the 30 g x 1/2 in.Bd¿ bulk, non-sterile needle.There was no report of injury or medical interventions.

• Brand Name: 30 G X 1/2 IN. BD¿ BULK, NON-STERILE NEEDLE
• Type of Device: HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6745510
• MDR Text Key: 81301077
• Report Number: 1911916-2017-00134
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2017

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: Other
• Device Catalogue Number: 302047
• Device Lot Number: 5175577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2017
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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
• Patient Outcome(s): Other