MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE

Catalog Number 324918

Device Problem Volume Accuracy Problem (1675)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/21/2021

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 the bd ultra-fine¿ insulin syringe experienced the cannula piercing through the shield prior to use.The patient received a needle stick injury from the exposed cannula.As a result, the patient expressed their intention to seek out medical testing for and potentially transmitted disease/infection.It has not been mentioned whether such testing has been received.The following information was provided by the initial reporter: the client was at the pharmacy and went to buy a package of syringes, but when she picked it up, she felt the perforation of one of the needles.Visualizing then that it was without the shield and the orange shield was loose in the package, which was sealed.She informed that the package was not on the counter but on the part exposed to customers in the pharmacy.Client mentioned that when she had the accidental perforation, a drop of blood came out and she will have to do some tests to check if he has not contracted any pathology.Package was sealed.Customer mentioned that she will carry out tests to verify if there has been contamination or exposure to any (b)(6).

Manufacturer Narrative

H6: investigation summary: customer returned several images of an unopened polybag for 1.0ml, 31 gauge, 6mm syringes from lot 1074331.There is a syringe inside the polybag that does not have a needle shield on it.The exposed needle present in the unopened polybag would be capable of causing a needle stick.A review of the device history record was completed for batch# 1074331.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Based on the images received, bd was able to confirm the customer¿s indicated failure of needle stick, patient harm, the shield missing/separating from the syringe.The root cause cannot be determined.

Event Description

It was reported that the bd ultra-fine¿ insulin syringe experienced the cannula piercing through the shield prior to use.The patient received a needle stick injury from the exposed cannula.As a result, the patient expressed their intention to seek out medical testing for and potentially transmitted disease/infection.It has not been mentioned whether such testing has been received.The following information was provided by the initial reporter: the client was at the pharmacy and went to buy a package of syringes, but when she picked it up, she felt the perforation of one of the needles.Visualizing then that it was without the shield and the orange shield was loose in the package, which was sealed.She informed that the package was not on the counter but on the part exposed to customers in the pharmacy.Client mentioned that when she had the accidental perforation, a drop of blood came out and she will have to do some tests to check if he has not contracted any pathology.Package was sealed.Customer mentioned that she will carry out tests to verify if there has been contamination or exposure to any sti.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12661729
• MDR Text Key: 281528935
• Report Number: 1920898-2021-01092
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324918
• Device Lot Number: 1074331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female