MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE

Catalog Number	UNKNOWN
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Initial reporter phone#: (b)(6).Device manufacture date: unknown.(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: unable to perform complaint lot history check due to an unknown lot number for needle clog, needle bent npe, needle bent pe, npi needle dull & npi needle pain.A review of all risk management documents for the product family of the device involved in this complaint (pen needle, needle clog, needle bent npe, needle bent pe, npi needle dull, npi needle pain), was performed and it was determined that the potential risk of this specific reported incident was captured and addressed.Investigation summary: customer returned photos of an open 4mm, 32 pen needle.Customer states that the needles were clogged, the needles were bent on the patient end and non patient end, the needles were dull, and there was pain.The photos were examined and exhibited a bent non patient end of the cannula, which could prevent insulin from flowing through the cannula properly.The photos did not exhibit a bent patient end of the cannula and it is difficult to determine if the samples in the photos exhibited a dull cannula point.Unable to perform dhr check due to an unknown lot number for needle clog, needle bent npe, needle bent pe, npi needle dull & npi needle pain.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent non patient end of the cannula, clogged).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (bent patient end of the cannula, dull).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: user error.No evidence of manufacturing related issues were observed on the returned samples.It is bd¿s experience that the non-patient end breakage and bending is directly associated with the placing of the needle onto the pen device by the user.If the non-patient end of the needle is not placed centrally to the pen device, then instead of the non-patient end of the needle piercing the rubber septum of the vial, it hits hard material and can be bent/broken when fitted to the pen.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Event or Problem Description
It was reported that unspecified bd¿ pen needle was unable to deliver insulin.This occurred on 4 occasions during use.The following information was provided by the initial reporter: caregiver informs that her daughter uses needles ultra-fine 4mm for too long, but recently 4 needles have caused the following issues: two were clogged.The customer noticed the issue after coupling the needle into the pen, in the flow test noticed that the insulin was not coming out.Other two needles were bent.One of them was bent in the inner side (non-patient end), and the other one was bent outside (patient end, noticed as soon as removed the safety cover from the needle)."it looks like the needle was dull", reported the customer.The caregiver reports that it caused too much pain to her daughter at the application moment.Applies 6 timer per day.Performs the rotation properly and does not reuse the device.

• 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: 10354050
• Report Number: 2243072-2020-01179
• Device Sequence Number: 19715029
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 08/01/2020
• 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