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 Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: level a 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 harm bruising/bleeding, npi needle pain, leakage & difficult/unable to operate.A review of all risk management documents as per (b)(4) for the product family of the device involved in this complaint (pen needle, npi needle pain, leakage & difficult/unable to operate), was performed and it was determined that the potential risk of this specific reported incident was captured and addressed.The reported harm, bruising/bleeding is directly associated with hazard: npi (needle point integrity).A review of all risk management documents as per (b)(4) for the product family of the device involved in this complaint (pen needle), was performed and it was determined that the potential risk of this specific reported incident was captured and addressed.Investigation summary: no samples 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.Unable to perform dhr check due to an unknown lot number for harm bruising/bleeding, npi needle pain, leakage & difficult/unable to operate.Investigation conclusion: as no samples and/or photo(s) were 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.
Event or Problem Description
It was reported that an unspecified bd pen needle leaked.The following information was provided by the initial reporter: "it was reported that consumer's medication came out of her injection site once when she did not pinch her skin before injecting, she had bruising at her injection sites on occasion where she injected with teriparatide.She also had pain at her injection sites where she injected verbatim: low blood pressure [hypotension], pounding in her ears [ear disorder], shin pain/ bone pain [bone pain], osteoarthritis [osteoarthritis], pain at her injection sites [injection site pain], bruising at her injection sites [injection site bruising], patient administered forteo sometimes without folding her skin before injecting needle, no ae [wrong technique in product usage process].Case description: this solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) years-old (at the time of initial report) female patient of an unknown origin.Medical history and concomitant medications were not provided.The patient received teriparatide (rdna origin) injections (forteo), via a prefilled pen, for the treatment of unknown indication, beginning on (b)(6) 2019.On an unknown date, while on teriparatide therapy, she experienced low blood pressure after she took teriparatide, that came and gone.She sat down when that occurred and ate salty chips, drank a coke and fluids, which helped to alleviate that.She did not feel good when that happened.She had pounding in her ears that came and gone.That did not happen every time she took teriparatide but did happened sometimes after taking teriparatide.On an unknown date, she had bruising at her injection sites on occasion where she injected with teriparatide.She also had pain at her injection sites where she injected.(batch number d167328j, pc number, (b)(4)).Both happened occasionally.She used the bd 31 g 5/16 inch needles, and that she did not always pinch her skin before injecting the needle.On an unknown date, she experienced that medication came out of her injection site once when she did not pinch her skin before injecting.On an unknown date, she experienced shin pain daily after starting teriparatide but that now occurred occasionally.She also experienced bone pain and osteoarthritis.She experienced occasional glitches with her teriparatide devices.She had trouble one month with her teriparatide device dripping medication after she injected.The outcome for the events, information regarding corrective treatment and teriparatide treatment was not provided.The operator of the device was patient and her training status was not provided.The general device model duration of use and suspect device duration of use were unknown but therapy started on (b)(6) 2019.The action taken with suspect device was not provided and its return was not expected.The initial reporting consumer did not provide relatedness assessment between the events and teriparatide drug or 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: 10285609
• Report Number: 2243072-2020-01076
• Device Sequence Number: 811407
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: Other
• 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: 07/02/2020
• Initial Report FDA Received Date: 07/16/2020
• 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
• Patient Age: 61 YR