MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BLOOD COLLECTION SET

Catalog Number SEE SECTION H.10

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Muscular Rigidity (1968); Vomiting (2144); Twitching (2172); Depression (2361); Reaction (2414); Sleep Dysfunction (2517); Lethargy (2560)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Without a sample, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that a consumer had severe reactions after having her blood drawn using an unspecified blood collection set.Symptoms included fever, lethargy, vomiting, depression, panic attack, fear, neurological issues, twitches, sleeping terrors and upper body rigidity, could not use her right hand.Specific medical interventions were not mentioned and we have been unable to obtain additional information.

• Brand Name: UNSPECIFIED BLOOD COLLECTION SET
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6994725
• MDR Text Key: 90868495
• Report Number: 2243072-2017-00202
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/01/2017

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
• Device Operator: Other
• Device Catalogue Number: SEE SECTION H.10
• Device Lot Number: SEE SECTION H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention