MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.3 ML BD MICRO-FINE +¿ INSULIN SYRINGE WITH 30G X 8 MM NEEDLE

Catalog Number 328838

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

Two lot numbers, 634534e and 634584a, were provided for this incident.However, these lot numbers do not exist for the reported catalog # 328838.Therefore, a manufacture date and an expiration date are unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported when drawing up the insulin with a 0.3 ml bd micro-fine +¿ insulin syringe with 30g x 8 mm needle it became black during use.No medical interventions provided.

Manufacturer Narrative

The holdrege plant is currently working on continuous improvement efforts surrounding print defects found within the plant and their associated root cause(s).Capa (b)(4) was initiated to address such issues at this time.

Manufacturer Narrative

Results: a review of the device history record was completed for batch # 6347584 the dhr shows there were two incidents noted during completion of the dhr/qn review for unrelated documentation issues.Customer returned (58) 3/10cc, 8mm, 30g syringes in open poly bags from lot # 6347584.Customer states that after withdrawing insulin, the drug inside insulin syringe became black as it should be clear.Nineteen syringes were returned with approximately 16 units of a cloudy liquid inside the barrel.All returned syringes were examined and 52 out of 58 samples exhibited dark material smeared on the surface of the barrel.No dark material was observed in the barrels.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis suggests that this material has components similar to those of scale print.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure (smeared ink on surface of barrel) possible root cause is attributed to pad swelling on the mandril during the printing process.As the pads are used, they gradually swell and can cause this type of "smear" or "smudge affect.A problem solving team has been tasked with improving print quality on all production lines within the plant.The team is systematically assessing and addressing each printer individually for improvements.The (b)(4) plant is currently working on continuous improvement efforts surrounding print defects found within the plant and their associated root cause(s).Capa (b)(4) was initiated to address such issues at this time.

• Brand Name: 0.3 ML BD MICRO-FINE +¿ INSULIN SYRINGE WITH 30G X 8 MM NEEDLE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6815607
• MDR Text Key: 83660411
• Report Number: 1920898-2017-00169
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K955235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 328838
• Device Lot Number: SEE SECTION H.10
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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