MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE INSULIN 1ML 30GA; INSULIN SYRINGE

Catalog Number 326780

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Loss of consciousness (2418)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: (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 syringe insulin 1ml 30ga experienced foreign matter in the fluid path.The lay user/patient received medication as a result of the incident.The following information was provided by the initial reporter: a customer bought a pack of ¿bd ultra-fine 1 ml¿ syringes (sku 14729) and within hours he returned upset, indicating that the syringes were open, representing a health hazard for the user.At the scene he requested to open another box and together with the pharmacy manager they realized that even though the box was closed and sealed, the inside of the bag was open.The patient, uses insulin syringes, wants to make a claim and report, because the product was already used.He indicated that after making use of the same that he bought in a pharmacy, he presented general discomfort, such as pain, loss of consciousness.Later, he realized that the syringes were used and fears that he is infected.When they went back to the pharmacy where they had purchased this product, they confirmed that there were other syringes in the same condition.I felt bad.It was a horrible discomfort, headache and spinal cord that left me lying on the floor approximately 1 hour, as soon as i recovered i proceeded to inspect the box to realize that some were contaminated without a needle and others with black residue inside them, probably rotten blood.

Manufacturer Narrative

H.6.Investigation: customer returned (10) 1cc, 13mm, 30g syringes in an open poly bag with the shelf carton from lot # 1088884.Customer states that the product was already used.All returned syringes were examined and 6 out of 10 samples exhibited a reddish material inside the barrel.A small amount of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely blood and insulin.This fm issue is also reported under investigation child record (b)(4).The blood and insulin would not have been acquired during the manufacturing process.During the documentary review, no quality events were reported in the process carried out in our facilities, the batch was inspected and later released in accordance with the current work instructions.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that the syringe insulin 1ml 30ga experienced foreign matter in the fluid path.The lay user/patient received medication as a result of the incident.The following information was provided by the initial reporter: a customer bought a pack of ¿bd ultra-fine 1 ml¿ syringes (sku 14729) and within hours he returned upset, indicating that the syringes were open, representing a health hazard for the user.At the scene he requested to open another box and together with the pharmacy manager they realized that even though the box was closed and sealed, the inside of the bag was open.The patient, uses insulin syringes, wants to make a claim and report, because the product was already used.He indicated that after making use of the same that he bought in a pharmacy, he presented general discomfort, such as pain, loss of consciousness.Later, he realized that the syringes were used and fears that he is infected.When they went back to the pharmacy where they had purchased this product, they confirmed that there were other syringes in the same condition.I felt bad.It was a horrible discomfort, headache and spinal cord that left me lying on the floor approximately 1 hour, as soon as i recovered i proceeded to inspect the box to realize that some were contaminated without a needle and others with black residue inside them, probably rotten blood.

• Brand Name: SYRINGE INSULIN 1ML 30GA
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12479170
• MDR Text Key: 271635729
• Report Number: 9614033-2021-00107
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326780
• Device Lot Number: 1088884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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): Other