MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT; MONITOR, MICROBIAL GROWTH

Catalog Number	249560
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.E.1.Initial reporter phone#: (b)(6).H.3.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It has been reported that the bd bactec¿ subculturing/aerobic venting unit has been found causing a needlestick injury during use.The following has been provided by the initial reporter: needlestick injury due to half sharp, half blunt end of needle.Can i make you aware of an issue with some bd venting needles.Looks like the metal bit is inverted - sharp sticking out and blunt end that normally makes contact with bottle seal was blunt.Unfortunately we had a needle stick over the weekend with bms inoculating patients blood into graze on her hand as hand slipped likely due to too much force needed to puncture bottle.
Additional Manufacturer Narrative
The following field was updated due to additional information: b5: describe event or problem: it has been reported that the bd bactec¿ subculturing/aerobic venting unit has been found causing a needlestick injury during use.The following has been provided by the initial reporter: needlestick injury due to half sharp, half blunt end of needle.Can i make you aware of an issue with some bd venting needles.Looks like the metal bit is inverted - sharp sticking out and blunt end that normally makes contact with bottle seal was blunt.Unfortunately we had a needle stick over the weekend with bms inoculating patients blood into graze on her hand as hand slipped likely due to too much force needed to puncture bottle.Staff member was placed on 7 days flucoxacillin as a precautionary measure due to the potential risk.Staff member is fit and well and has not had any further symptoms following this exposure.H.6.Investigation summary: this memo serves to summarize findings on your recent complaint 9036592 on product 249560 (vent aerobic 50 ea), lot number 1342258, where it was observed that there was a device with a cannula that was too blunt causing a needlestick injury.Event description: "needlestick injury due to half sharp, half blunt end of needle." complaint history review: a review of past complaints on this product over the past 12 months does not indicate a trend on this issue.Device history record review: a review of the device history record did not indicate any manufacturing issues.Sample analysis: a review of the photo provided does not indicate any defects.The retention sample inspection was satisfactory.Evaluations results: based on the investigation, no defect was observed.No complaint trend is present for this batch.Investigation conclusion: based on the evaluation of the investigation, the complaint was not confirmed.As no deviations were observed in the investigation, no corrective or preventive actions are indicated at this time.Bd will continue to monitor for trending.
Event or Problem Description
It has been reported that the bd bactec¿ subculturing/aerobic venting unit has been found causing a needlestick injury during use.The following has been provided by the initial reporter: needlestick injury due to half sharp, half blunt end of needle.Can i make you aware of an issue with some bd venting needles.Looks like the metal bit is inverted - sharp sticking out and blunt end that normally makes contact with bottle seal was blunt.Unfortunately we had a needle stick over the weekend with bms inoculating patients blood into graze on her hand as hand slipped likely due to too much force needed to puncture bottle.Staff member was placed on 7 days flucoxacillin as a precautionary measure due to the potential risk.Staff member is fit and well and has not had any further symptoms following this exposure.

• Brand Name: BD BACTEC¿ SUBCULTURING/AEROBIC VENTING UNIT
• Common Device Name: MONITOR, MICROBIAL GROWTH
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18079425
• Report Number: 1024879-2023-00786
• Device Sequence Number: 7729227
• Product Code: JTA
• UDI-Device Identifier: 00382902495604
• UDI-Public: (01)00382902495604
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 249560
• Device Lot Number: 1342258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown