MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD PEN NEEDLE

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problems Bruise/Contusion (1754); Pain (1994); Underdose (2542)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check could not be performed for the defect/condition reported since the lot number was not provided.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Dhr could not be performed as the lot number was not provided.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.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 in and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that the unknown bd pen needle was unable to dispense insulin/medication during use.The customer reported, "the patient received teriparatide (rdna origin) injections (forteo), via a pre-filled pen, 20 mcg, once daily, subcutaneously, for the treatment of osteoporosis, beginning on (b)(6) 2018.On an unknown date, after starting teriparatide treatment, when she started a new pen the injections stung for the first few days and then resolved.She also got a lot of bruising at the injection site and she liked to inject in leg instead of stomach but she did not had enough subcutaneous tissue.Also since an unknown date in (b)(6) 2018, she had been leaving almost half the medication in the pen once her 28 days was finished (pc number: (b)(4) and batch number: unknown).She rotated her injection site daily but did not inject in her thighs anymore because it hurt.All the pens that she had used so far except for the first one had a lot of drug left in it.The orange cap of the plunger was a little under the last little (small) black line near the tip when one would attach the needle for her (b)(6) pen and that with other pens orange cap would always be around that point to when she stopped using it.She started her (b)(6) pen on the (b)(6) 2019 (or (b)(6) 2019 conflicting date) and used it for the last time on (b)(6) 2019 (pc number: unknown and batch number: c774581c).She did not use pen for more than 28 days and was upset to pay so much and throw away that much drug each month.She did not use the same needle twice, used bd needles and pen never blocked or leaked.She did not prime pen.Since (b)(6) 2019, her new pen that she was now using the orange cap was a little under the first longer black line closer to the blue plastic pen.She knew how to inject as per was a nurse.On an (b)(6) 2019, she used the pen for more than 28 days.The event of injection site pain was recovered.Information regarding corrective treatment and outcome of the remaining events was not provided.Teriparatide therapy was continued¿.

• Brand Name: UNKNOWN BD PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8430241
• MDR Text Key: 142652905
• Report Number: 2243072-2019-00510
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2019

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/18/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other