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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE Back to Search Results
Catalog Number 324916
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field."multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7142871, expiration date: 2022-06-30 , manufacture date: 2017-05-22.Medical device lot #: 7142871, expiration date: 2022-06-30, device manufacture date: 2017-05-22.(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 during use of the bd ultra-fine¿ insulin syringe when removing the shield from the syringe, the needle detached from the tip.In a second package two problems were noted the needle was loose and discarded the product, while the other when removing the shield noticed that it was missing the needle.There was no report of injury or medical intervention.
 
Event Description
It was reported that during use of the bd ultra-fine¿ insulin syringe when removing the shield from the syringe, the needle detached from the tip.In a second package two problems were noted the needle was loose and discarded the product, while the other when removing the shield noticed that it was missing the needle.There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: customer returned (1) 3/10cc syringe and (1) 1/2cc syringe in an open poly bag for 3/10cc, 6mm, 31g syringes from lot # 7142871.Customer states that the needle detached from the tip, the needle was loose, when removing the shield noticed that it was missing the needle, there are air bubbles, the syringe is smoked, and visualization of the scale markings is difficult.Both returned syringes were examined and no foreign matter was observed on either of the samples and no defects were observed on the scale markings printed on each of the barrels.The 3/10cc syringe was returned with the hub-needle/shield assembly separated from the barrel.The 1/2cc syringe was returned with a missing cannula and no adhesive observed in the hub.No air bubbles were observed in either of the samples.Capa 97451 has been opened to address the hub separates issue.Capa 91661 has been opened to address the adhesive issue.Samples were forwarded to manufacturing (holdrege) on 26oct2018 for further review.On 29oct2018, holdrege received one (1) loose 0.3ml, 6mm, 31g syringe in opened polybag for batch# 7142871.Additionally, one (1) loose 0.5ml syringe was received from an unreported batch number.All samples were decontaminated per hstr-17 and hqa-68 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.For the 0.3ml returned sample, the sample was received with the needle assembly disassembled from the remainder of the barrel, presumably representing the hub separates portion of this complaint.Additionally, the 0.5ml returned sample was received without a cannula affixed within the hub/shield.For the returned 0.3ml sample exhibiting a hub separation, no damage was noted to the hub core, nor the barrel tip at the time of evaluation.This likely represents an event in-which the needle assembly did not fully engage the "snap-fit" design of the device, and thus the hub became disengaged at some later time, likely during transit or during initial activation of the device by the end user.Capa 97451 and 539107 were initiated by the holdrege plant to address hub separates and their associated root cause(s).Batch# 7142871 was manufactured prior to implementation activities of either capa.For the returned 0.5ml sample exhibiting a missing cannula and adhesive, probable root cause is a missed cannulation of the hub, in which no adhesive would have been applied on the equipment.Generally, when this occurs, the adhesive may be found on the next subsequent part, however that is unable to be verified at this time.Capa 91661 was initiated by the holdrege plant to address adhesive run-over onto the hub, including failed cannulation, and their associated root cause(s).As there is no batch information provided for this sample, verification of date of manufacture, as it relates to corrective/preventive actions associated with this capa is unable to be completed.A review of the device history record was completed for batch # 7142871 all inspections were performed per the applicable operations qc specifications.There were five (5) notifications [200706680, 200707042, 200706829, 200704388, 200704205] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle loose and needle missing on lot # 7142871.Unable to perform complaint lot history check for needle hub separates, air bubbles, fm on syringe and scale illegible on the unknown lot number.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates, missing cannula, insufficient adhesive) - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (fm and scale marking issues, air bubbles) 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.
 
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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
MDR Report Key7903997
MDR Text Key121708560
Report Number1920898-2018-00737
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup
Report Date 11/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number324916
Device Lot NumberSEE H.10
Date Manufacturer Received09/03/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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