MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE

Catalog Number UNKNOWN

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 05/10/2019

Event Type  malfunction  

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).Medical device expiration date: unknown.Device evaluated by mfr: a device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that unspecified bd¿ pen needle leaked medication and was unable to deliver.This was discovered during use.The following information was provided by the initial reporter: material no.: unknown, batch no.: unknown.Complaint 1 of 3 - addresses occurrence date (b)(6).It was reported the consumer noticed medication leaking from where the needle was screwed to the pen.Verbatim: the patient received teriparatide (rdna origin) injections (forteo) via a prefilled pen, at an unknown dose once daily via for the treatment of osteoporosis beginning on (b)(6) 2019 or (b)(6) 2019.On (b)(6) 2019, while on teriparatide treatment, she noticed medication leaking from where needle was screwed to the pen.She noticed this leaking from her three teriparatide injections on (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019.The leaking happened with each injection when she would take using the bd ultra-fine needles.There was more than one drop of medication leaked each time and did not get actual dose of teriparatide (pc: (b)(4); lot number: unknown).The event incorrect dose administered was considered as serious due to medical significance reason.As of (b)(6) 2019, she was in hospital.Information regarding corrective treatment, outcome of the event and status of teriparatide treatment was not provided.Patient was the operator of the device and her training status was not provided.The device general model duration of use was not provided but started on (b)(6) 2019 and suspect device duration was not reported.The action taken with suspect device was not provided and its return was expected.The reporting pharmacist did not know whether the event was related to teriparatide drug or not but related the event with teriparatide device issue.

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr could not be performed as the lot number was not provided.

Event Description

It was reported that unspecified bd¿ pen needle leaked medication and was unable to deliver.This was discovered during use.The following information was provided by the initial reporter: material no.: unknown batch no.: unknown.Complaint 1 of 3 - addresses occurrence date (b)(6).It was reported the consumer noticed medication leaking from where the needle was screwed to the pen.Verbatim: the patient received teriparatide (rdna origin) injections (forteo) via a prefilled pen, at an unknown dose once daily via for the treatment of osteoporosis beginning on (b)(6) -2019 or (b)(6) 2019.On (b)(6) 2019, while on teriparatide treatment, she noticed medication leaking from where needle was screwed to the pen.She noticed this leaking from her three teriparatide injections on (b)(6) 2019, (b)(6) 2019 and (b)(6) 2019.The leaking happened with each injection when she would take using the bd ultra-fine needles.There was more than one drop of medication leaked each time and did not get actual dose of teriparatide ((b)(4); lot number: unknown).The event incorrect dose administered was considered as serious due to medical significance reason.As of (b)(6) 2019, she was in hospital.Information regarding corrective treatment, outcome of the event and status of teriparatide treatment was not provided.Patient was the operator of the device and her training status was not provided.The device general model duration of use was not provided but started on 03-apr-2019 and suspect device duration was not reported.The action taken with suspect device was not provided and its return was expected.The reporting pharmacist did not know whether the event was related to teriparatide drug or not but related the event with teriparatide device issue.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8773679
• MDR Text Key: 150533395
• Report Number: 2243072-2019-01358
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other