MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 30GA 7/8IN BSG CLEAR HUB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	302890
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The customer's address is unknown: (b)(6) usa has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a needle 30ga 7/8in bsg clear hub had excessive flash on the hub.The following was reported, "material no.302890 batch no.8145979.It was reported there is excessive flash on hubs."as february 18, it was received pir (b)(4) customer complaint, dr.Stated ¿order of anterior chamber cannulas, 30ga, seems to have excessive flash on the hubs.Often on all four corners of the hub with some of the flash up to 4mm.See attached photo for an example.We are having to deburr the hubs as we work through the inventory¿.Would you please help us with defect root cause investigation and help us to fill section 2 and 3 of scar form attached.".
Additional Manufacturer Narrative
Correction: describe event or problem: it was reported that a needle 30ga 7/8in bsg clear hub had excessive flash on the hub.The following was reported, material no.302890 batch no.8145979.It was reported there is excessive flash on hubs.As february 18, it was received pir 74236 customer complaint, dr.Stated order of anterior chamber cannulas, 30ga, seems to have excessive flash on the hubs.Often on all four corners of the hub with some of the flash up to 4mm.We are having to deburr the hubs as we work through the inventory.Investigation summary: photo was received for investigation.Defect is confirmed.There was no documentation of issues for the complaint of batch #8145979 during the production run.Molding process-- root cause is related to the molding cavity insert.When the cavity insert starts to deteriorate the flash becomes very visible (note; the mold cavity insert is a piece of metal).As soon it is detected, the machine gets stopped, the cavity is blocked and the cavity mold insert is replaced later on during preventive maintenance.These samples were escapes from this.Corrective and preventive actions: the mold insert was changed during preventive maintenance.
Event or Problem Description
It was reported that a needle 30ga 7/8in bsg clear hub had excessive flash on the hub.The following was reported, material no.302890 batch no.8145979.It was reported there is excessive flash on hubs.As february 18, it was received pir 74236 customer complaint, dr.Stated order of anterior chamber cannulas, 30ga, seems to have excessive flash on the hubs.Often on all four corners of the hub with some of the flash up to 4mm.We are having to deburr the hubs as we work through the inventory.

• Brand Name: NEEDLE 30GA 7/8IN BSG CLEAR HUB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8412755
• Report Number: 1911916-2019-00258
• Device Sequence Number: 13899395
• Product Code: FMI
• UDI-Device Identifier: 50382903028905
• UDI-Public: 50382903028905
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 302890
• Device Lot Number: 8145979
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/12/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other