MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD AUTOSHIELD DUO SAFETY PEN NEEDLE

Catalog Number 329505

Device Problems Failure to Deliver (2338); Difficult or Delayed Activation (2577)

Patient Problem Underdose (2542)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified number of bd autoshield¿ duo safety pen needles were unable to deliver insulin/medication, experienced safety shield failure, and were involved with a serious injury -medical intervention during use.After administering a dose of insulin to a patient, it was noticed that the needle remained within the device, leading the device operator to question whether the proper dose was administered.As a result, the patient required subsequent monitoring by health care professionals.The following information was provided by the initial reporter: material no: 329505, batch no: 9266406.One of our nurse was administering insulin to a patient.She noticed following that the needle was stuck inside and did not retract properly.We do not know if this occurred before the insulin was administered or after so therefore do not know whether this patient received their insulin or not.As we were aware of the defect we were able to monitor the patient.If this had not been noticed by the nurse there may have been serious adverse event for this patient.The top needle is what should happen when the needle works correctly and what happened with the one she used.Per customer's response: do you have physical samples? no the needle in question was discarded.Are you requesting replacement? no.We were wanting to know if this was an ongoing problem with this product or if it was just a one-off.We have brought this to the attention of our nursing staff so they are aware to check following the injection that the needle retracts properly.Was the consumer able to maintain glucose levels since it was uncertain if insulin was injected? yes they were.Was another dose administered? no there was not another dose given as we could not confirm if they had received the initial dose.Patient was monitored with no adverse effects.No serious harm was reported.Unfortunately, the device is not available for investigation.

Manufacturer Narrative

H.6.Investigation: customer returned photos of 5mm, 30g autoshield duo samples with the shelf carton from lot # 9266406.Customer states that he needle was stuck inside and did not retract properly.The attached photos were examined and exhibited one sample that was not properly activated, which could lead to an incomplete dose.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Three photos were returned from lot.No.9266406, cat.No.329505.Visual examination of the returned photos was carried out and a bent cannula was observed.Based on the photo and the fact no physical sample was returned for investigation this cannot be confirmed to be manufacturing related.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of bd autoshield¿ duo safety pen needles were unable to deliver insulin/medication, experienced safety shield failure, and were involved with a serious injury -medical intervention during use.After administering a dose of insulin to a patient, it was noticed that the needle remained within the device, leading the device operator to question whether the proper dose was administered.As a result, the patient required subsequent monitoring by health care professionals.The following information was provided by the initial reporter: material no: 329505; batch no: 9266406.One of our nurse was administering insulin to a patient.She noticed following that the needle was stuck inside and did not retract properly.We do not know if this occurred before the insulin was administered or after so therefore do not know whether this patient received their insulin or not.As we were aware of the defect we were able to monitor the patient.If this had not been noticed by the nurse there may have been serious adverse event for this patient.The top needle is what should happen when the needle works correctly and what happened with the one she used.Per customer's response: do you have physical samples? no, the needle in question was discarded.Are you requesting replacement? no, we were wanting to know if this was an ongoing problem with this product or if it was just a one-off.We have brought this to the attention of our nursing staff so they are aware to check following the injection that the needle retracts properly.Was the consumer able to maintain glucose levels since it was uncertain if insulin was injected? yes, they were.Was another dose administered? no, there was not another dose given as we could not confirm if they had received the initial dose.Patient was monitored with no adverse effects.No serious harm was reported.Unfortunately, the device is not available for investigation.

• Brand Name: BD AUTOSHIELD DUO SAFETY PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10077430
• MDR Text Key: 191672675
• Report Number: 9616656-2020-00439
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 329505
• Device Lot Number: 9266406
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other