MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE

Catalog Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use, the needle separated from the hub and the entire needle was lodged in consumers thumb with an unspecified bd pen needle.The following information was provided by the initial reporter: it was reported by the consumer that the needle separated from the hub and lodged into his thumb, the entire needle was in his thumb resulting in the consumer having surgery to have the needle removed.Additional information provided: consumer reported back in (b)(6) 2019, when he removed the shield from a short pen needle, the needle only, separated from the hub and got lodged in his thumb; stated it was as though the needle was "spring loaded" because it shot forward.Stated the entire needle was in his thumb, there was no piece of needle remaining in hub.Stated: he waited until (b)(6), hoping the needle would make its way out of his thumb but instead, it developed a callus and became uncomfortable.Stated he went to hospital, surgery was performed by hand surgeon and needle was removed.Does not have any product to send back, does not have needle that was removed from his thumb.Stated he would try to locate the box.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check due to an unknown lot number for separates, needle stick & harm.H3 other text : see h.10.
Event or Problem Description
It was reported that during use the needle separated from the hub and the entire needle was lodged in consumers thumb with an unspecified bd pen needle.The following information was provided by the initial reporter: it was reported by the consumer that the needle separated from the hub and lodged into his thumb, the entire needle was in his thumb resulting in the consumer having surgery to have the needle removed.Additional information provided: consumer reported back in (b)(6) of 2019, when he removed the shield from a short pen needle, the needle only, separated from the hub and got lodged in his thumb; stated it was as though the needle was "spring loaded" because it shot forward.Stated the entire needle was in his thumb, there was no piece of needle remaining in hub.Stated: he waited until (b)(6), hoping the needle would make its way out of his thumb but instead, it developed a callus and became uncomfortable.Stated he went to hospital, surgery was performed by hand surgeon and needle was removed.Does not have any product to send back, does not have needle that was removed from his thumb.Stated he would try to locate the box.

• Brand Name: UNSPECIFIED BD PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8778639
• Report Number: 2243072-2019-01376
• Device Sequence Number: 1937688
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 07/22/2019
• 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