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

Catalog Number UNKNOWN

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 07/16/2019

Event Type  malfunction  

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.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s2; occurrence: unable to perform complaint lot history check due to an unknown lot number for glucose level, preactivation & leakage.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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 glucose level, preactivation & leakage.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 Description

It was reported that unspecified bd¿ pen needles were unable to deliver insulin.This was discovered during use.The following information was provided by the initial reporter: material no: unknown batch no: unknown it was reported that the patient possibly did not administer full dose of humalog as there was pooling at injection site, sae bg elevated.Verbatim: the patient received insulin lispro (rdna origin) (humalog, 100 u/ml) via a pre-filled pen (junior kwikpen), unknown dose and frequency, subcutaneously, for the treatment of type-i diabetes and started on unknown date.On an unknown date, while on insulin lispro treatment, he did not feel the injection go in, that the shield blocked the needle and the nurse had to re-inject for him to receive their dose.His blood sugars were stable after this injection.It was felt that the nurse twisted the bd auto needle shield onto the pen too tight causing it to lock into place.When the injections were given to him subsequently, the nurse noted pooling at the injection site.The nurse was using the bd autoshield and could see the insulin come to the tip of the needle when priming but that she did not know if the pooling that was seen on the skin after the two subsequent injections was from the full dose of the insulin not being delivered to him or if the pooling was from the insulin from priming that stayed inside the shield and then came out onto the skin when the pen was pointed downward during the injection.With the two injections, when pooling was noted he did experience a higher blood sugar level that needed to be corrected.It was not sure if the elevated blood sugar was from the pooling and he was not receiving the full dose or if it was part of his disease process.He was hospitalized for these events and no other information was received regarding hospitalization.Information regarding corrective treatment and outcome for the events was not provided.Status of insulin lispro treatment was not provided.The operator of the device was nurse and was trained.The kwikpen device model and suspect kwikpen duration of use was not provided.The action taken was not provided and its return was not provided.The reporting consumer was unknown if the events were related to insulin lispro drug or kwikpen.The case was cross-referenced with the case (b)(4).Elevated blood sugar [blood glucose increased].Patient possibly did not administer full dose of humalog as there was pooling at injection site, sae bg elevated [incorrect dose administered].Case description: this spontaneous case, reported by nurse via sales representative, who contacted the company to report adverse events and product complain, concerned a male patient of unknown age and origin.Medical history and concomitant medications were not provided.

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLES
• 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: 8856155
• MDR Text Key: 153886713
• Report Number: 2243072-2019-01580
• 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: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 08/02/2019
• 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