MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367001
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device brand name: bd vacutainer® blood alcohol determinations sodium fluoride: 100 mg potassium oxalate: 20 mg.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9158872, medical device expiration date: 2021-06-30, device manufacture date: 2019-06-07, medical device lot #: 9184893, medical device expiration date: 2021-07-31, device manufacture date: 2019-07-03, medical device lot #: 9280864, medical device expiration date: 2021-10-31, device manufacture date: 2019-10-07.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100 mg potassium oxalate: 20 mg an unknown volatile was found to be off-gassing into sample by laboratory personnel.There was no reported patient impact.The following information was provided by the initial reporter: an unknown and unexpected volatile was found to be off-gassing into our forensic blood alcohol samples.I actually identified two sources, ptfe/butyl crimp cap septa of the perkin elmer gas chromatograph vials used for analysis and also bd grey top stoppers of 10 ml 100 mg sodium fluoride/20 mg potassium oxalate vacutainers (catalog number 367001).The volatile was recently identified by hs-gc-ms as 2-butene at another laboratory for us.The appearance of this unexpected volatile is a recent phenomenon and i suspect several manufacturers purchase the raw rubber product for their applications from limited suppliers.Although 2-butene is easily separated from our analysis of interest via analysis by dual column headspace gas chromatography and does not interfere with the identification and quantitation of ethanol, it does co-elute with methanol on one of our columns.We report methanol qualitatively, but other laboratories may report it quantitatively.A contaminant introduced into a forensic blood alcohol sample during sample collection or processing needs to be eliminated if possible.We were able to eliminate one source of the 2-butene by changing our crimp caps to ptfe/silicon.We do not see a way to eliminate the bd source as easily due to lack of an alternative stopper on the validated tube.There is additionally a limited availability of the specified grey top tubes from other manufacturers.It is even possible the other manufacturers would contain it as well.Our agency purchases the blood alcohol specimen collection kits which contain the bd grey top vacutainers from arrowhead forensics.The current lot number that appears to be most affected is 9280864.However, 9158872 and 9184893 were also found to contain it.
Event or Problem Description
It was reported that during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg an unknown volatile was found to be off-gassing into sample by laboratory personnel.There was no reported patient impact.The following information was provided by the initial reporter: an unknown and unexpected volatile was found to be off-gassing into our forensic blood alcohol samples.I actually identified two sources, ptfe/butyl crimp cap septa of the perkin elmer gas chromatograph vials used for analysis and also bd grey top stoppers of 10 ml 100 mg sodium fluoride/20 mg potassium oxalate vacutainers (catalog number 367001).The volatile was recently identified by hs-gc-ms as 2-butene at another laboratory for us.The appearance of this unexpected volatile is a recent phenomenon and i suspect several manufacturers purchase the raw rubber product for their applications from limited suppliers.Although 2-butene is easily separated from our analytes of interest via analysis by dual column headspace gas chromatography and does not interfere with the identification and quantitation of ethanol, it does co-elute with methanol on one of our columns.We report methanol qualitatively, but other laboratories may report it quantitatively.A contaminant introduced into a forensic blood alcohol sample during sample collection or processing needs to be eliminated if possible.We were able to eliminate one source of the 2-butene by changing our crimp caps to ptfe/silicon.We do not see a way to eliminate the bd source as easily due to lack of an alternative stopper on the validated tube.There is additionally a limited availability of the specified grey top tubes from other manufacturers.It is even possible the other manufacturers would contain it as well.Our agency purchases the blood alcohol specimen collection kits which contain the bd grey top vacutainers from arrowhead forensics.The current lot number that appears to be most affected is 9280864.However, 9158872 and 9184893 were also found to contain it.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for evaluation.Therefore, 10 retention samples of each of the incident lot were selected from bd inventory for further testing.Customer demonstrated interference with methanol was due to 2-methyl-propene (isobutene), not 2-butene as originally suggested based on further customer investigation.2-methyl-propene has been confirmed in the bac tube (chlorobutyl stopper) by bd through a third party analytical vendor in all complaint lot and control lot tubes tested, as well as in other bromobutyl and chlorobutyl stoppered products unrelated to this complaint.2-methyl-propene (isobutene) is a raw material in the butyl rubber manufacturing process so residual isobutene is likely.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Based on the additional testing completed, this complaint has been confirmed for the presence of residual isobutene.

• Brand Name: SEE H.10
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10603172
• Report Number: 1917413-2020-00890
• Device Sequence Number: 1192875
• Product Code: JKA
• UDI-Device Identifier: 50382903670012
• UDI-Public: 50382903670012
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K901449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 367001
• Device Catalogue Number: 367001
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 09/09/2020
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other